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

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ReVENT Sleep Apnea System
Sponsored by
Revent Medical International B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ReVENT Sleep Apnea System

    Arm Description

    All patients will be implanted with the ReVENT Sleep Apnea System

    Outcomes

    Primary Outcome Measures

    Apnea-Hypopnea Index (AHI)
    Decrease in polysomnographically measured AHI post-intervention compared to baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2015
    Last Updated
    November 3, 2016
    Sponsor
    Revent Medical International B.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02501304
    Brief Title
    Feasibility Study of the ReVENT Sleep Apnea System
    Acronym
    REV-001
    Official Title
    Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Revent Medical International B.V.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea (OSA)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ReVENT Sleep Apnea System
    Arm Type
    Experimental
    Arm Description
    All patients will be implanted with the ReVENT Sleep Apnea System
    Intervention Type
    Device
    Intervention Name(s)
    ReVENT Sleep Apnea System
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Apnea-Hypopnea Index (AHI)
    Description
    Decrease in polysomnographically measured AHI post-intervention compared to baseline
    Time Frame
    24 months post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Feasibility Study of the ReVENT Sleep Apnea System

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