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Feasibility Study of the ReVENT Sleep Apnea System | Clinical Trials | Clareo Health

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COMPLETEDNANCT02501304

Feasibility Study of the ReVENT Sleep Apnea System

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.

Lead sponsor: Revent Medical International B.V.•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Revent Medical International B.V.

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 4, 2016Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment40

Start dateMay 2011

Last updatedNov 4, 2016

Condition

Obstructive Sleep Apnea (OSA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2016Data synced to Clareo: July 12, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions