Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT00549159
Status:
UNKNOWN
Last Update Posted:
2008-05-22
First Post:
2007-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CavatermTM vs TCRE in Women With DUB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008796', 'term': 'Metrorrhagia'}, {'id': 'D008595', 'term': 'Menorrhagia'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-19', 'studyFirstSubmitDate': '2007-10-24', 'studyFirstSubmitQcDate': '2007-10-24', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'SF-12, Patients Wishes and Expectations questionnaire, adverse events, need for re-treatment', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['menorrhagia', 'dysfunctional uterine bleeding', 'endometrial ablation'], 'conditions': ['Dysfunctional Uterine Bleeding']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to compare the treatment success in the study groups.', 'detailedDescription': 'Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC\\<75.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness and adequate mental capacity to sign written, informed consent\n* Willingness to adhere to study plan regarding control visits and recording of PBLAC\n* \\> 30 years old\n* Pre-menopausal as determined by FSH ≤30\n* Agree not to use hormonal contraception or any other intervention for bleeding during study\n* Suitable for local and/or general anesthesia\n* A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy\n* Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm.\n\nExclusion Criteria:\n\n* Presence of bacteriaemia, sepsis, or other active systemic infection\n* Active pelvic inflammatory disease\n* Clotting defects or bleeding disorders\n* Unwillingness to use a non-hormonal birth control post-ablation\n* Desire for future fertility\n* Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as \\< 2 cm are in this context not considered abnormal.\n* Any condition leading to possible uterine wall weakness with total wall thickness \\< 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured.\n* Premalignant or malignant uterine condition within the last five years as confirmed by histology\n* Pregnancy\n* Cervical length \\> 6 cm.\n* Uterine cavity \\>30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures).\n* Previous ablation or subtotal hysterectomy'}, 'identificationModule': {'nctId': 'NCT00549159', 'briefTitle': 'CavatermTM vs TCRE in Women With DUB', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pnn Medical A/S'}, 'officialTitle': 'Multicenter Randomized Clinical Trial to Evaluate the Safety and Effectiveness of Cavaterm TM Thermal Balloon Endometrial Ablation in Women With Dysfunctional Uterine Bleeding Compared to Transcervical Resection of the Endometrium (TCRE)', 'orgStudyIdInfo': {'id': '2006-0026-06 dd20070920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cavaterm', 'interventionNames': ['Device: Thermal Balloon Endometrial Ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TCRE', 'description': 'Transcervical resection of the endometrium', 'interventionNames': ['Device: Transcervical Resection of the Endometrium']}], 'interventions': [{'name': 'Thermal Balloon Endometrial Ablation', 'type': 'DEVICE', 'description': 'Thermal balloon endometrial ablation', 'armGroupLabels': ['Cavaterm']}, {'name': 'Transcervical Resection of the Endometrium', 'type': 'DEVICE', 'description': 'Transcervical resection of the endometrium', 'armGroupLabels': ['TCRE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shi Lei Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhu Jiang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanhong Yu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Guangzhou Southern Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yanhong Yu, Prof.', 'role': 'CONTACT', 'email': 'yuyh20050712@hotmail.com', 'phone': '+862061641017'}, {'name': 'Nan Liu, MD', 'role': 'CONTACT', 'email': 'annan0103@yahoo.com.cn', 'phone': '+8613889903451'}], 'overallOfficials': [{'name': 'Yanhong Yu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangzhou Southern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pnn Medical A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Gediminas Puras, Clinical Trial Manager', 'oldOrganization': 'Pnn Medical A/S'}}}}