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

NCT02180815 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2017-04-04

No results posted yet for this study

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

Interventions

DEVICE

ReVENT Sleep Apnea System

Sponsors & Collaborators

  • Revent Medical, Inc.

    collaborator INDUSTRY

  • Revent Medical International B.V.

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Wolfgang Bergler · St. Joseph-Stift

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Belgium
  • Czechia
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02180815 on ClinicalTrials.gov