Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-27 @ 10:37 AM
Study NCT ID:
NCT02501304
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of the ReVENT Sleep Apnea System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-10-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2015-07-14', 'dispFirstSubmitQcDate': '2016-11-03', 'studyFirstSubmitQcDate': '2015-07-15', 'dispFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': '24 months post-procedure', 'description': 'Decrease in polysomnographically measured AHI post-intervention compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of OSA with AHI 15-40\n* Body Mass Index (BMI) ≤ 32\n* Refused or failed Continuous Positive Airway Pressure (CPAP)\n* Evidence of airway collapse at soft palate and/or base of tongue\n\nExclusion Criteria:\n\n* Prior OSA surgery\n* Anatomy unable to accommodate implants\n* Chronic immunosuppressive therapy or known problems with wound healing\n* Type I or II diabetes\n* Active systemic infection\n* Pregnancy\n* Other major medical conditions that could confound outcome measures or interfere with study completion'}, 'identificationModule': {'nctId': 'NCT02501304', 'acronym': 'REV-001', 'briefTitle': 'Feasibility Study of the ReVENT Sleep Apnea System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revent Medical International B.V.'}, 'officialTitle': 'Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)', 'orgStudyIdInfo': {'id': 'REV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReVENT Sleep Apnea System', 'description': 'All patients will be implanted with the ReVENT Sleep Apnea System', 'interventionNames': ['Device: ReVENT Sleep Apnea System']}], 'interventions': [{'name': 'ReVENT Sleep Apnea System', 'type': 'DEVICE', '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', 'armGroupLabels': ['ReVENT Sleep Apnea System']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revent Medical International B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}