Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01328067
Status:
WITHDRAWN
Last Update Posted:
2018-06-15
First Post:
2011-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D017699', 'term': 'Pelvic Pain'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063186', 'term': 'Uterine Myomectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-04-01', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '36 months post treatment', 'description': 'Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.'}, {'measure': 'Efficacy', 'timeFrame': '36 months post treatment', 'description': 'Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).'}], 'secondaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '36 months post treatment', 'description': "1. Post treatment change in patient's quality of life\n2. Post treatment change in pelvic pain\n3. Post treatment Change in bleeding\n4. Post treatment recovery time"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRgFus', 'Uterine Fibroids', 'Pelvic Pain', 'Quality of Life', 'Symptomatic Uterine Fibroids'], 'conditions': ['Uterine Fibroids', 'Bleeding', 'Pelvic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.insightec.com', 'label': "Sponsor's website"}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.\n\nWomen, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.\n\nAll patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.\n\nPatients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women age 18 or older\n2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).\n3. Women who have given written informed consent\n4. Women who are able and willing to attend all study visits\n5. Patient is pre or peri-menopausal (within 12 months of last menstrual period)\n6. Able to communicate sensations during the ExAblate procedure\n7. Uterine fibroids, which are device accessible\n8. Fibroid(s) clearly visible on non-contrast MRI.\n9. Fibroid(s) enhances on MR contrast imaging\n\nExclusion Criteria:\n\n1. Women currently pregnant\n2. Uterine size \\> 24 cm W/O the cervix\n3. More than 4 clinically significant fibroids (per MRI)\n4. Prior myomectomy, UAE\n5. Allergy to either gadolinium or iodinated contrast\n6. Implanted metallic device prohibiting MRI\n7. Severe claustrophobia\n8. Active pelvic infection\n9. Current use of intrauterine contraceptive device\n10. Unstable medical conditions requiring additional monitoring during the procedure\n11. Bleeding diathesis requiring medical treatment\n12. Imaging suggestive of malignant disease of uterus, ovary, or cervix\n13. Imaging and suggestive of adenomyosis.\n14. Pedunculated submucosal or pedunculated subserosal myoma\n15. Size and weight which prohibits subject from fitting in MRI device\n16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path.\n17. Hyper intense fibroid relatively to the uterus muscle\n18. Women with ovarian dermoid cyst anywhere in the treatment path'}, 'identificationModule': {'nctId': 'NCT01328067', 'briefTitle': 'Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'InSightec'}, 'officialTitle': 'A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids', 'orgStudyIdInfo': {'id': 'UF034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'MR guided Focused Ultrasound', 'interventionNames': ['Device: Exablate 2100']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'Myomectomy', 'interventionNames': ['Procedure: Myomectomy']}], 'interventions': [{'name': 'Exablate 2100', 'type': 'DEVICE', 'description': 'MRgFUS', 'armGroupLabels': ['Treatment']}, {'name': 'Myomectomy', 'type': 'PROCEDURE', 'description': 'Non-Hysteroscopic Myomectomy', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Wady Gedroyc, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Mary's Hospital, London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InSightec', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}