Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2011-05-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ReVENT Sleep Apnea System
All patients will be implanted with the ReVENT Sleep Apnea System
ReVENT Sleep Apnea System
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
Interventions
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ReVENT Sleep Apnea System
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Revent Medical International B.V.
INDUSTRY
Responsible Party
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Other Identifiers
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REV-001
Identifier Type: -
Identifier Source: org_study_id