Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01369758
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2010-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MyoSure Hysteroscopic Tissue Removal System Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D011127', 'term': 'Polyps'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Christina.Mastandrea@Hologic.com', 'phone': '508-263-8772', 'title': 'Christina Mastandrea', 'organization': 'Hologic, Inc'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intrauterine Pathology, Myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.\n\nMyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.', 'otherNumAtRisk': 278, 'otherNumAffected': 5, 'seriousNumAtRisk': 278, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cervical Trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pedal Edema Post-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 278, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedure Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intrauterine Pathology, Myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.\n\nMyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '96.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour post treatment', 'description': 'Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure', 'unitOfMeasure': 'percent of pathology', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects That Achieve 100% Removal of Target Pathology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intrauterine Pathology, Myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.\n\nMyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '69.5', 'upperLimit': '79.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour post treatment', 'description': 'Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intrauterine Pathology, Myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.\n\nMyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intrauterine Pathology, Myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.\n\nMyoSure Tissue Removal System: The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '278', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '278', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '290 Subjects enrolled. Nine (9) subjects removed from analysis because they did not meet the inclusion criteria. Three (3) subjects removed from analysis because they met the exclusion criteria.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2010-11-11', 'resultsFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-09', 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Efficacy', 'timeFrame': '1 hour post treatment', 'description': 'Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects That Achieve 100% Removal of Target Pathology', 'timeFrame': '1 hour post treatment', 'description': 'Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['morcellator', 'hysteroscope', 'myomectomy', 'polypectomy', 'uterine fibroids', 'uterine polyps'], 'conditions': ['Uterine Fibroids', 'Polyps']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.', 'detailedDescription': 'Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy female between 18 and 65 years of age\n2. Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her\n3. Subject is indicated for myomectomy or polypectomy\n4. Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:\n\n * All polyps\n * All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter\n * Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter\n\nExclusion Criteria:\n\n1. Subject is pregnant\n2. Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure\n3. Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin\n4. Active pelvic inflammatory disease or pelvic/vaginal infection\n5. Subject has a known or suspected coagulopathy or bleeding disorder\n6. Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)\n7. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study"}, 'identificationModule': {'nctId': 'NCT01369758', 'briefTitle': 'MyoSure Hysteroscopic Tissue Removal System Registry Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hologic, Inc.'}, 'officialTitle': 'MyoSure Hysteroscopic Tissue Removal System Registry Study', 'orgStudyIdInfo': {'id': 'TMP 200905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intrauterine pathology, myomectomy', 'description': 'Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.', 'interventionNames': ['Device: MyoSure Tissue Removal System']}], 'interventions': [{'name': 'MyoSure Tissue Removal System', 'type': 'DEVICE', 'otherNames': ['Myomectomy procedure'], 'description': 'The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.', 'armGroupLabels': ['Intrauterine pathology, myomectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01752', 'city': 'Marlborough', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Hologic, Inc.', 'geoPoint': {'lat': 42.34593, 'lon': -71.55229}}], 'overallOfficials': [{'name': 'Edward Evantash', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hologic, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hologic, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}