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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
| 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 :
- 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
| 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
| Contact: Scott Skorupa | 952-641-4440 | sskorupa@respicardia.com |
Locations
| 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
| 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 |
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.
|
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| 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 |
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| Condition ICMJE | Sleep Apnea Syndromes | ||||
| Intervention ICMJE | Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System
|
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| Study Arms ICMJE | Experimental: Transvenous nerve stimulation
Intervention: Device: Transvenous nerve stimulation
|
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Respicardia, Inc. | ||||
| Study Sponsor ICMJE | Respicardia, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Respicardia, Inc. | ||||
| Verification Date | February 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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