Feasibility Study of the ReVENT Sleep Apnea System | NCT02501304

Studies
Feasibility Study of the ReVENT Sleep Apnea System

NCT02501304

Sponsor

Revent Medical International B.V.

Status

Completed

Last Update Posted

Nov 4, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea (OSA)

Interventions

ReVENT Sleep Apnea System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Aug 2013Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jul 14, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Oct 3, 2016

Certification/Extension First Submitted that Passed QC Review

Nov 3, 2016

Certification/Extension First Posted Date

Nov 4, 2016Estimated

Last Update Submitted Date

Nov 3, 2016

Last Update Posted Date

Nov 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ReVENT Sleep Apnea System	Experimental	All patients will be implanted with the ReVENT Sleep Apnea System	Device: ReVENT Sleep Apnea System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReVENT Sleep Apnea System	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided