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出境医 / 临床实验 / A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI

A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI

Study Description
Brief Summary:
A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI

Condition or disease Intervention/treatment Phase
BPH Device: ITind device implant Not Applicable

Detailed Description:

Study Objective:

To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.

Efficacy Endpoints:

The endpoints of this study are:

  • Decrease in transition zone volume
  • Monitor size and location of ablative lesions
  • Monitor change in time of lesions
  • Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: iTind arm
ITind device implant
 Device: ITind device implant
device implanted for 5-7 days
Outcome Measures
Primary Outcome Measures :
  1. AE rate [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of device related adverse events.

  2. Unexpected SAE [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.

  3. Device complications [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male with symptomatic BPH
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject signed informed consent form (ICF)
  • Age 40 and above- Male with symptomatic BPH.
  • IPSS symptom severity score ≥ 13
  • Peak urinary flow of < 12 ml/sec
  • Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
  • Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
  • Subject able to comply with the study protocol
  • Normal urinalysis and negative urine culture
  • Subjects that are able to undergo MRI.

Exclusion Criteria:

  • A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
  • Confirmed or suspected bladder cancer;
  • Recent (within 3 months) cystolithiasis or hematuria;
  • Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
  • An active urinary tract infection.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
  • Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  • Median lobe obstruction of the prostate (larger than 1cm).
  • Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years)
  • Patient with renal dysfunction
  • Any serious medical condition likely to impede successful completion of the study
Contacts and Locations

Locations
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Germany
Kliniken Nordoberpfalz AG Klinik für Urologie, Kinderurologie und interdisziplinäres Prostatakarzinomzentrum
Weiden, Germany
Sponsors and Collaborators
Medi-Tate Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Thomas Bschleipfer, Prof. Weiden Clinic
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE November 18, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • AE rate [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of device related adverse events.
  • Unexpected SAE [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of unexpected serious adverse events deemed as related to Meditate iTIND and/or to implantation/retrieval procedures.
  • Device complications [ Time Frame: 12 months ]
    Incidence (% of subjects) and frequency (no. of events) of Meditate iTIND and/or to implantation/retrieval procedures complications
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI
Official Title  ICMJE A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)
Brief Summary A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI
Detailed Description

Study Objective:

To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed.

Efficacy Endpoints:

The endpoints of this study are:

  • Decrease in transition zone volume
  • Monitor size and location of ablative lesions
  • Monitor change in time of lesions
  • Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE BPH
Intervention  ICMJE Device: ITind device implant
device implanted for 5-7 days
Study Arms  ICMJE Experimental: iTind arm
ITind device implant
Intervention: Device: ITind device implant
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject signed informed consent form (ICF)
  • Age 40 and above- Male with symptomatic BPH.
  • IPSS symptom severity score ≥ 13
  • Peak urinary flow of < 12 ml/sec
  • Prostate volume between 25 ml to 80 ml (assessed by pre-operative ultrasound - TRUS)
  • Blood CBC and biochemistry up to two weeks before screening, demonstrating: Normal values of the PT, PTT and INR tests (Anticoagulants washout may be done two weeks prior of device implantation)
  • Subject able to comply with the study protocol
  • Normal urinalysis and negative urine culture
  • Subjects that are able to undergo MRI.

Exclusion Criteria:

  • A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
  • Confirmed or suspected bladder cancer;
  • Recent (within 3 months) cystolithiasis or hematuria;
  • Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
  • An active urinary tract infection.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
  • Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  • Median lobe obstruction of the prostate (larger than 1cm).
  • Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years)
  • Patient with renal dysfunction
  • Any serious medical condition likely to impede successful completion of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Male with symptomatic BPH
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03994263
Other Study ID Numbers  ICMJE MT-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medi-Tate Ltd.
Study Sponsor  ICMJE Medi-Tate Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Bschleipfer, Prof. Weiden Clinic
PRS Account Medi-Tate Ltd.
Verification Date February 2021

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

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