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出境医 / 临床实验 / Janus Feasibility Study

Janus Feasibility Study

Study Description
Brief Summary:
The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System implant procedure.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: Transvenous nerve stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Transvenous Nerve Stimulation Study (Janus Study)
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Transvenous nerve stimulation Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System
Outcome Measures
Primary Outcome Measures :
  1. Changes in respiration and airway physiology [ Time Frame: During procedure (immediately post-stimulation) ]
    The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System implant.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is at least 18 years old
  • Subject with moderate to severe central sleep apnea is undergoing a commercial remedē® System implant
  • Subject is willing and able to give informed consent

Exclusion Criteria:

  • Subject is unable or unwilling to participate with study procedures
  • Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the remedē system implant)
  • Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
  • Subject has body mass index (BMI) > 40 kg/m2 at the time of implant
  • Subject has had prior neck surgery
  • Previous or currently implanted upper airway stimulation device
  • Subject has had prior oral cavity surgery that may interfere with breathing
  • Subject has significant upper airway-related anatomic anomaly
  • Subject is enrolled in concurrent study that may confound the results of this study
  • Subject is taking muscle relaxant medication unless approved by the site implanter and Respicardia clinical staff
  • Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Contacts and Locations

Contacts
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Contact: Scott Skorupa 952-641-4440 sskorupa@respicardia.com

Locations
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United States, North Carolina
Novant Health Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27013
Contact: Carla Perez    336-718-5807      
Principal Investigator: Michael Drucker, MD         
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sarah Brougher    614-292-3962      
Principal Investigator: Ralph Augostini, MD         
United States, Pennsylvania
Bryn Mawr Medical Specialists Association Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Anne Henry    610-525-1202      
Principal Investigator: Sheetal Chandhok, MD         
Sponsors and Collaborators
Respicardia, Inc.
Investigators
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Study Director: Tim Meyer, MS, PhD Respicardia, Inc.
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE January 9, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019) 		Changes in respiration and airway physiology [ Time Frame: During procedure (immediately post-stimulation) ]
The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System implant.
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 Janus Feasibility Study
Official Title  ICMJE Transvenous Nerve Stimulation Study (Janus Study)
Brief Summary The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System implant procedure.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Sleep Apnea Syndromes
Intervention  ICMJE Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System
Study Arms  ICMJE Experimental: Transvenous nerve stimulation
Intervention: Device: Transvenous nerve stimulation
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: June 12, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is at least 18 years old
  • Subject with moderate to severe central sleep apnea is undergoing a commercial remedē® System implant
  • Subject is willing and able to give informed consent

Exclusion Criteria:

  • Subject is unable or unwilling to participate with study procedures
  • Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the remedē system implant)
  • Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
  • Subject has body mass index (BMI) > 40 kg/m2 at the time of implant
  • Subject has had prior neck surgery
  • Previous or currently implanted upper airway stimulation device
  • Subject has had prior oral cavity surgery that may interfere with breathing
  • Subject has significant upper airway-related anatomic anomaly
  • Subject is enrolled in concurrent study that may confound the results of this study
  • Subject is taking muscle relaxant medication unless approved by the site implanter and Respicardia clinical staff
  • Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Scott Skorupa 952-641-4440 sskorupa@respicardia.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985527
Other Study ID Numbers  ICMJE CR1389
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: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Respicardia, Inc.
Study Sponsor  ICMJE Respicardia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tim Meyer, MS, PhD Respicardia, Inc.
PRS Account Respicardia, Inc.
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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