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

Revent Medical

Status: Completed

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Device: ReVENT Sleep Apnea System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02501304

REV-001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ReVENT Sleep Apnea System

Experimental group

Description:

All patients will be implanted with the ReVENT Sleep Apnea System

Treatment:

Device: ReVENT Sleep Apnea System