Feasibility Study of the ReVENT Sleep Apnea System

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: ReVENT Sleep Apnea System

• Registration Number: NCT02501304
• Lead Sponsor: Revent Medical International B.V.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-08
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Study Completion: 2016-04
• Disposition First Submitted: 2016-10-03
• Status Verified: 2016-11
• Disposition First Submitted QC: 2016-11-03
• Last Update Submitted: 2016-11-03
• Disposition First Posted: 2016-11-04
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReVENT Sleep Apnea System	ReVENT Sleep Apnea System	All patients will be implanted with the ReVENT Sleep Apnea System

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	24 months post-procedure	Decrease in polysomnographically measured AHI post-intervention compared to baseline