NCT02180815

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

ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Revent Medical International B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	ReVENT Sleep Apnea System

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-07-03
• Last updated: 2017-04-04

Locations

14 sites across 5 countries: Belgium, Czechia, Germany, Netherlands, Switzerland