Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-04-22 @ 2:54 PM
Study NCT ID:
NCT02349893
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2015-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'samuel.faran@olympus.com', 'phone': '0049 1607168798', 'title': 'Dr Samuel Faran', 'organization': 'Olympus Europa SE & Co. KG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This was a multicenter single-arm study. Further randomized controlled trails are needed to obtain higher level of evidence.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were documented from first RFA treatment until the final follow-up visit after 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'RFA Treatment', 'description': 'RFA treatment performed with CelonProSleep plus device\n\nRFA treatment: RFA treatment using CelonProSleep plus system', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RFA Treatment', 'description': 'RFA treatment performed with Celon ProSleep plus device, three treatment sessions of RF ablation of the soft palate (7 lesions) and the base of tongue (6 lesions)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.86', 'spread': '8.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months following last treatment', 'description': 'The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.', 'unitOfMeasure': 'No. of apneas/hypopneas per h of sleep', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The apnea hypopnea index after the treatment was analyzed for all study completers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RFA Treatment', 'description': 'RFA treatment performed with Celon ProSleep plus device, three treatment sessions of RF ablation of the soft palate (7 lesions) and the base of tongue (6 lesions)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RFA Treatment', 'description': 'RFA treatment performed with Celon ProSleep plus device, three treatment sessions of RF ablation of the soft palate (7 lesions) and the base of tongue (6 lesions)'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Study completers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.67', 'spread': '11.20', 'groupId': 'BG000'}]}]}, {'title': 'Study dropouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.75', 'spread': '8.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Study completers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Study dropouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Apnea Hypopnea Index', 'classes': [{'title': 'Study completers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.70', 'spread': '7.10', 'groupId': 'BG000'}]}]}, {'title': 'Study dropouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.15', 'spread': '6.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'No. of apneas/hypopneas per h of sleep', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Results are presented separately for study completers (n=43) and study dropouts (n=13). The overall number of baseline participants is n=56 including all study completers and study dropouts.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-09-26', 'size': 821338, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-01T03:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2015-01-24', 'resultsFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2015-01-24', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-27', 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Apnea Hypopnea Index (AHI) at 6 Months Post-baseline', 'timeFrame': '6 months following last treatment', 'description': 'The primary endpoint is the apnea hypopnea index (AHI) at 6 months post-baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Apnea, Sleep']}, 'descriptionModule': {'briefSummary': 'The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure, daytime sleepiness, and increased risk of motor vehicle accidents.\n\nThis study was design in order to evaluate the CelonProSleep plus for multi-level radiofrequency ablation (RFA) of the palate and base of tongue as a treatment for mild to moderate obstructive sleep apnea syndrome (OSAS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥ 22 years)\n* Self-report of daytime somnolence\n* Body mass index (BMI) ≤ 32\n* Mild to moderate obstructive sleep apnea (AHI 10 - 30; lowest O2 sat ≥ 80%)\n* Evidence of palate and tongue base collapse on supine fiberoptic examination\n* Non-compliant with or refusal of continuous positive airway pressure therapy (CPAP) (\\< 4 hours per night by patient report)\n* No prior surgical treatment for OSAS other than nasal surgery\n* Willing and capable of providing informed consent\n\nExclusion Criteria:\n\n* Another significant sleep disorder (e.g., insomnia, periodic limb movement)\n* Tonsillar hypertrophy\n* Chronic Obstructive Pulmonary Disease (COPD)\n* Interstitial Lung Disease (ILD)\n* Cystic Fibrosis\n* Acute Repiratory Distress Syndrome (ARDS)\n* Nasal or supraglottic obstruction on fiberoptic examination\n* American Society of Anesthesiologists (ASA) class III ,IV, V\n* Latex allergy\n* Lidocaine allergy\n* Pregnancy or plans to become pregnant Note: women of childbearing potential must demonstrate a negative pregnancy test upon enrollment; those patients qualified to progress to RFA must also demonstrate a negative pregnancy test within 7 days prior to the date of RFA procedure.\n* Major depression or non-stabilized psychiatric disorder\n* Drug or alcohol abuse\n* Previous palatal or tongue surgery\n* Stable or unstable angina\n* congestive heart failure (CHF)\n* moderate or severe valvular disease\n* transient ischemic attack (TIA)/cardiovascular accident (CVA)\n* Carotid stenosis or endarterectomy\n* Anemia\n* Room air oxygen saturation (SpO2) \\< 95%\n* Pulmonary hypertension\n* Dialysis\n* Central or mixed apnea ≥ 10% of respiratory events\n* Participation in another clinical study (enrolled in any concurrent study) whose investigational plan is judged to interfere or affect any of the measures of this study'}, 'identificationModule': {'nctId': 'NCT02349893', 'briefTitle': 'Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olympus Surgical Technologies Europe'}, 'officialTitle': 'Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA treatment', 'description': 'RFA treatment performed with CelonProSleep plus device', 'interventionNames': ['Device: RFA treatment']}], 'interventions': [{'name': 'RFA treatment', 'type': 'DEVICE', 'description': 'RFA treatment using CelonProSleep plus system', 'armGroupLabels': ['RFA treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90212', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Alessi Clinic', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80909', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'Otolaryngology Colorado', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'ENT of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bluesleep clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29425-8570', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Institutional Review Board for Human Research (IRB)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Healthcare Foundation', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Shaun Nguyen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olympus Surgical Technologies Europe', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}