Feasibility Study of the ReVENT Sleep Apnea System (REV-001)

November 3, 2016 updated by: Revent Medical International B.V.

Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of OSA with AHI 15-40
  • Body Mass Index (BMI) ≤ 32
  • Refused or failed Continuous Positive Airway Pressure (CPAP)
  • Evidence of airway collapse at soft palate and/or base of tongue

Exclusion Criteria:

  • Prior OSA surgery
  • Anatomy unable to accommodate implants
  • Chronic immunosuppressive therapy or known problems with wound healing
  • Type I or II diabetes
  • Active systemic infection
  • Pregnancy
  • Other major medical conditions that could confound outcome measures or interfere with study completion

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReVENT Sleep Apnea System
All patients will be implanted with the ReVENT Sleep Apnea System
Device: ReVENT Sleep Apnea System
The ReVENT Sleep Apnea System consists of minimally invasive biocompatible devices that are placed into the tongue base and palate of patients with obstructive sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: 24 months post-procedure
Decrease in polysomnographically measured AHI post-intervention compared to baseline
24 months post-procedure

Collaborators and Investigators

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

Sponsor

Revent Medical International B.V.

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

May 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REV-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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