Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 7:45 AM
Study NCT ID:
NCT01436903
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2011-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-07', 'studyFirstSubmitDate': '2011-08-12', 'studyFirstSubmitQcDate': '2011-09-18', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postsurgical change in bleeding patterns dependent on cavum probe length.', 'timeFrame': 'Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea.'}, {'measure': 'Postsurgical change in patient satisfaction dependent on cavum probe length.', 'timeFrame': 'Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'The questionnaire will ask for satisfaction and recommendation to the best friend.'}], 'secondaryOutcomes': [{'measure': 'Postsurgical change in dyspareunia', 'timeFrame': 'A questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'The questionnaire will ask for pre- and postsurgical dyspareunia.'}, {'measure': 'Postsurgical change in Premenstrual Syndrome', 'timeFrame': 'A questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.'}, {'measure': 'Prevention of further gynaecological therapies', 'timeFrame': 'A questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'The questionnaire will ask for postsurgical hysterectomy and further medications.'}, {'measure': 'Improvement of quality of life', 'timeFrame': 'A questionnaire will be sent in September 2010, at least after one postsurgical year.', 'description': 'The questionnaire will ask for postsurgical quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menorrhagia', 'dysfunctional uterine bleeding', 'endometrial ablation', 'cavatermTM', 'probe'], 'conditions': ['Menorrhagia']}, 'descriptionModule': {'briefSummary': 'CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CavatermTM operation because of menorrhagia\n* timeframe: January 2006 till August 2009\n* older than 29 years and younger than 56 years\n\nExclusion Criteria:\n\n* pregnancy\n* fragmentary filled questionnaire\n* more than 1 CavatermTM operation'}, 'identificationModule': {'nctId': 'NCT01436903', 'briefTitle': 'Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length, a Questionnaire Investigation on 290 Patients', 'orgStudyIdInfo': {'id': '743/2010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thermal Balloon Endometrial Ablation', 'type': 'DEVICE', 'otherNames': ['CavatermTM'], 'description': 'Thermal Balloon Endometrial Ablation for 10 minutes after curettage'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2620', 'city': 'Neunkirchen', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Landesklinikum Thermenregion Neunkirchen', 'geoPoint': {'lat': 47.72096, 'lon': 16.08107}}], 'overallOfficials': [{'name': 'Beda W. Hartmann, Univ.-Doz.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Doz. Dr. Mag.', 'investigatorFullName': 'Beda Hartmann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}