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出境医 / 临床实验 / Intercostal Nerve Cryoablation for Postoperative Pain Management

Intercostal Nerve Cryoablation for Postoperative Pain Management

Study Description
Brief Summary:
The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Intercostal Nerve Cryoablation Drug: Bupivacaine liposomal injectable suspension Drug: Patient-controlled analgesia (PCA) Phase 4

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intercostal Nerve Cryoablation for Postoperative Pain Management
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
Device: Intercostal Nerve Cryoablation
Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
Other Name: CryoICE® CRYO2 cryoablation probes (AtriCure, Inc)

Drug: Bupivacaine liposomal injectable suspension
Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
Other Name: Exparel® (Pacira Pharmacoceuticals)

Drug: Patient-controlled analgesia (PCA)
Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.

Active Comparator: Standard of Care (SOC) Pain Control Drug: Bupivacaine liposomal injectable suspension
Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
Other Name: Exparel® (Pacira Pharmacoceuticals)

Drug: Patient-controlled analgesia (PCA)
Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.

Outcome Measures
Primary Outcome Measures :
  1. Score on Numeric Pain Scale (NPS) [ Time Frame: post-operative day 5 ]
    The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain.

  2. Brief Pain Inventory (BPI) - severity score [ Time Frame: baseline ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  3. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 3 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  4. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 4 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  5. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 5 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  6. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 30 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  7. Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 180 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.

  8. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: baseline ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  9. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 3 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  10. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 4 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  11. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 5 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  12. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 30 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  13. Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 180 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.

  14. 5-point satisfaction scale [ Time Frame: post-operative day 3 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".

  15. 5-point satisfaction scale [ Time Frame: post-operative day 4 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".

  16. 5-point satisfaction scale [ Time Frame: post-operative day 5 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".

  17. 5-point satisfaction scale [ Time Frame: post-operative day 30 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".

  18. 5-point satisfaction scale [ Time Frame: post-operative day 180 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".


Secondary Outcome Measures :
  1. Total amount in mg of opioid medication consumed [ Time Frame: third to fifth post-operative days after surgery ]
  2. Number of participants who require of opioids at the time of discharge [ Time Frame: at the time of discharge (about a week after surgery) ]
  3. Number of participants who utilize patient-controlled analgesia (PCA) [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  4. Amount of patient-controlled analgesia (PCA) used [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  5. Number of participants who attain physical therapy goal that justifies discharge from inpatient physical therapy within 72 hours [ Time Frame: 72 hours after surgery ]
  6. Length of hospital stay [ Time Frame: at the time of discharge (about a week after surgery) ]
  7. Hospital cost for patient care during hospitalization [ Time Frame: at the time of discharge (about a week after surgery) ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Descending/thoracoabdominal incision is planned
  • There is reasonable expectation that the patient will be extubated within 48 hours after surgery

Exclusion Criteria:

  • The patient has a known allergy to morphine or any opioid
  • The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
  • The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 48 hours after surgery There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Joshua Wong, MBE 713-486-5131 Joshua.wong@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Joshua Wong, MBE    713-486-5131    Joshua.wong@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Anthony L Estrera, MD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Score on Numeric Pain Scale (NPS) [ Time Frame: post-operative day 5 ]
    The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: baseline ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 3 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 4 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 5 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 30 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - severity score [ Time Frame: post-operative day 180 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: baseline ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 3 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 4 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 5 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 30 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • Brief Pain Inventory (BPI) - pain interference score [ Time Frame: post-operative day 180 ]
    The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
  • 5-point satisfaction scale [ Time Frame: post-operative day 3 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
  • 5-point satisfaction scale [ Time Frame: post-operative day 4 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
  • 5-point satisfaction scale [ Time Frame: post-operative day 5 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
  • 5-point satisfaction scale [ Time Frame: post-operative day 30 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
  • 5-point satisfaction scale [ Time Frame: post-operative day 180 ]
    The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Total amount in mg of opioid medication consumed [ Time Frame: third to fifth post-operative days after surgery ]
  • Number of participants who require of opioids at the time of discharge [ Time Frame: at the time of discharge (about a week after surgery) ]
  • Number of participants who utilize patient-controlled analgesia (PCA) [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  • Amount of patient-controlled analgesia (PCA) used [ Time Frame: from the time immediately after surgery to post-operative day 3 ]
  • Number of participants who attain physical therapy goal that justifies discharge from inpatient physical therapy within 72 hours [ Time Frame: 72 hours after surgery ]
  • Length of hospital stay [ Time Frame: at the time of discharge (about a week after surgery) ]
  • Hospital cost for patient care during hospitalization [ Time Frame: at the time of discharge (about a week after surgery) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intercostal Nerve Cryoablation for Postoperative Pain Management
Official Title  ICMJE Intercostal Nerve Cryoablation for Postoperative Pain Management
Brief Summary The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Device: Intercostal Nerve Cryoablation
    Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
    Other Name: CryoICE® CRYO2 cryoablation probes (AtriCure, Inc)
  • Drug: Bupivacaine liposomal injectable suspension
    Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
    Other Name: Exparel® (Pacira Pharmacoceuticals)
  • Drug: Patient-controlled analgesia (PCA)
    Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
Study Arms  ICMJE
  • Experimental: Intercostal Nerve Cryoablation plus SOC Pain Control
    Standard of Care (SOC)
    Interventions:
    • Device: Intercostal Nerve Cryoablation
    • Drug: Bupivacaine liposomal injectable suspension
    • Drug: Patient-controlled analgesia (PCA)
  • Active Comparator: Standard of Care (SOC) Pain Control
    Interventions:
    • Drug: Bupivacaine liposomal injectable suspension
    • Drug: Patient-controlled analgesia (PCA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Descending/thoracoabdominal incision is planned
  • There is reasonable expectation that the patient will be extubated within 48 hours after surgery

Exclusion Criteria:

  • The patient has a known allergy to morphine or any opioid
  • The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
  • The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 48 hours after surgery There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua Wong, MBE 713-486-5131 Joshua.wong@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972397
Other Study ID Numbers  ICMJE HSC-MS-19-0283
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anthony L Estrera, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony L Estrera, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP