REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT02180815
- Lead Sponsor
- Revent Medical International B.V.
- Brief Summary
The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
- AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
- BMI ≤ 32.
- Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).
- Patient with prior tongue-base surgery
- Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
- History of mandibular and/or hyoid advancement to treat OSA.
- Any contraindications as listed in the approved Instructions for Use.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Apnea-Hypopnea Index (AHI) 3, 6 and 12 months
- Secondary Outcome Measures
Name Time Method Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life 3, 6 and 12 months
Related Research Topics
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Trial Locations
- Locations (14)
Cliniques Universitaires Saint Luc
🇧🇪Bruxelles, Belgium
University Hospital Antwerp
🇧🇪Edegem, Belgium
Pavelec LENTE, Ltd.
🇨🇿Plzeň, Czech Republic
St Joseph-Stift
🇩🇪Bremen, Germany
Alfried Krupp Krankenhaus
🇩🇪Essen, Germany
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
St. Franziskus Hospital HNO-Klinik
🇩🇪Köln, Germany
Universitäts-HNO-Klinik Mannheim
🇩🇪Mannheim, Germany
Klinikum Ernst von Bergmann
🇩🇪Potsdam, Germany
Universitätsklinikum HNO-Klinik
🇩🇪Ulm, Germany
Scroll for more (4 remaining)Cliniques Universitaires Saint Luc🇧🇪Bruxelles, Belgium