Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-25 @ 1:24 AM
Study NCT ID:
NCT02844920
Status:
COMPLETED
Last Update Posted:
2019-09-20
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tfarazi@gynesonics.com', 'phone': '650-216-3878', 'title': 'Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)', 'organization': 'Gynesonics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation\n\nIntrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Gall Stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation\n\nIntrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with completed follow-up assessment and had evaluable hysteroscopy videos.'}, {'type': 'SECONDARY', 'title': 'Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation\n\nIntrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation\n\nIntrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Completed Without Evaluable Videos', 'achievements': [{'comment': 'Participants with completed the follow-up but without evaluable hysteroscopy videos', 'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Completed With Evaluable Videos', 'achievements': [{'comment': 'Participants with completed the follow-up and evaluable hysteroscopy videos', 'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Completed, Eval. Data, Opposing Fibroids', 'achievements': [{'comment': 'Participants with completed the follow-up, evaluable hysteroscopy videos, and opposing fibroids', 'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants with completed the follow-up', 'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.4', 'spread': '7.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.4', 'spread': '5.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-01', 'size': 1512807, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-06T18:08', 'hasProtocol': True}, {'date': '2018-10-16', 'size': 1512289, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-06T18:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2016-07-22', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-18', 'studyFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids', 'timeFrame': '6 weeks', 'description': 'Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.'}], 'secondaryOutcomes': [{'measure': 'Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated', 'timeFrame': '6 weeks', 'description': 'As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Uterine Fibroids', 'Adhesions']}, 'descriptionModule': {'briefSummary': 'This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.', 'detailedDescription': 'Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.\n\nResearch participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who desire treatment of intrauterine fibroids with RF ablation via the Sonata System.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding\n* Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)\n* Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements\n\nExclusion Criteria:\n\n* Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator\n* One or more Type 0 fibroids and/or endometrial polyps of any size\n* Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT02844920', 'acronym': 'OPEN', 'briefTitle': 'Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gynesonics'}, 'officialTitle': 'Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids', 'orgStudyIdInfo': {'id': 'CL04897'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibroid Treatment', 'description': 'Intrauterine ultrasound guided radio-frequency ablation', 'interventionNames': ['Device: Intrauterine ultrasound guided radio-frequency ablation']}], 'interventions': [{'name': 'Intrauterine ultrasound guided radio-frequency ablation', 'type': 'DEVICE', 'otherNames': ['Sonata System'], 'description': 'Radiofrequency ablation for the treatment of uterine fibroids', 'armGroupLabels': ['Fibroid Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Klinikum Mannheim Universitäts- Frauenklinik Medizinische Fakultät Mannheim der Universität Heidelberg', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Klinikum Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum (MMC)', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitätsklinik für Frauenheilkunde Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynesonics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}