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

March 30, 2017 updated by: Revent Medical International B.V.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Edegem, Belgium
        • University Hospital Antwerp
  • Czech Republic
      • Plzeň, Czech Republic, 30101
        • Pavelec LENTE, Ltd.
  • Germany
      • Bremen, Germany, 28209
        • St Joseph-Stift
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus
      • Hamburg, Germany, 21075
        • Asklepios Klinik Harburg
      • Köln, Germany, 50825
        • St. Franziskus Hospital HNO-Klinik
      • Mannheim, Germany, 68135
        • Universitäts-HNO-Klinik Mannheim
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann
      • Ulm, Germany, 89075
        • Universitätsklinikum HNO-Klinik
  • Netherlands
      • Amsterdam, Netherlands
        • MC Slotervaart
      • Nieuwegein, Netherlands
        • Sint Antonius Hospital
      • Zwolle, Netherlands
        • ISALA Afdeling KNO-Heelkunde Isala
  • Switzerland
      • Liestal, Switzerland, 4410
        • Cantonal Hospital Baselland - ENT Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ReVENT implanted group
Device: ReVENT Sleep Apnea System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in Apnea-Hypopnea Index (AHI)
Time Frame: 3, 6 and 12 months
3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life
Time Frame: 3, 6 and 12 months
3, 6 and 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Safety profile assessed by incidence of adverse events
Time Frame: 1 week, 6 and 12 months
1 week, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revent Medical International B.V.

Collaborators

Revent Medical, Inc.

Investigators

  • Principal Investigator: Prof. Dr. Wolfgang Bergler, St. Joseph-Stift

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REV 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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