Feasibility Study of the ReVENT Sleep Apnea System

Obstructive Sleep Apnea (OSA) Clinical Trial

— REV-001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501304
• Other study ID #: REV-001
• Status: Completed
• Phase: N/A
• First received: July 14, 2015
• Last updated: November 3, 2016
• Start date: May 2011
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Revent Medical International B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaCzech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revent Medical International B.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI)	Decrease in polysomnographically measured AHI post-intervention compared to baseline	24 months post-procedure	No