REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea
NCT ID: NCT02180815
Last Updated: 2017-04-04
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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TERMINATED
50 participants
OBSERVATIONAL
2014-09-30
2017-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ReVENT implanted group
ReVENT Sleep Apnea System
Interventions
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ReVENT Sleep Apnea System
Eligibility Criteria
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Inclusion Criteria
* AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
* BMI ≤ 32.
* Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).
Exclusion Criteria
* Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
* History of mandibular and/or hyoid advancement to treat OSA.
* Any contraindications as listed in the approved Instructions for Use.
18 Years
ALL
No
Sponsors
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Revent Medical, Inc.
INDUSTRY
Revent Medical International B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. Wolfgang Bergler
Role: PRINCIPAL_INVESTIGATOR
St. Joseph-Stift
Locations
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Cliniques Universitaires Saint Luc
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
Pavelec LENTE, Ltd.
Pilsen, , Czechia
St Joseph-Stift
Bremen, , Germany
St. Franziskus Hospital HNO-Klinik
Cologne, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Asklepios Klinik Harburg
Hamburg, , Germany
Universitäts-HNO-Klinik Mannheim
Mannheim, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
Universitätsklinikum HNO-Klinik
Ulm, , Germany
MC Slotervaart
Amsterdam, , Netherlands
Sint Antonius Hospital
Nieuwegein, , Netherlands
ISALA Afdeling KNO-Heelkunde Isala
Zwolle, , Netherlands
Cantonal Hospital Baselland - ENT Department
Liestal, , Switzerland
Countries
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Other Identifiers
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REV 002
Identifier Type: -
Identifier Source: org_study_id
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