REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea

Revent Medical

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Device: ReVENT Sleep Apnea System

Study type: Observational

Funder types: Industry

Identifiers

NCT02180815

REV 002

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

50 participants in 1 patient group

ReVENT implanted group

Treatment:

Device: ReVENT Sleep Apnea System