Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-03-06 @ 10:54 PM
Study NCT ID:
NCT02100904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2014-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 578}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fibroid-related symptoms after the RFA or myomectomy procedure.', 'timeFrame': 'Baseline to 3 years', 'description': 'We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life.'}], 'secondaryOutcomes': [{'measure': 'Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure.', 'timeFrame': 'Baseline to 6 weeks'}, {'measure': 'Operative complications', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder.'}, {'measure': 'Pregnancy rate after the RFA or myomectomy procedure.', 'timeFrame': 'Baseline to 3 years'}]}, 'conditionsModule': {'keywords': ['Fibroids', 'Radiofrequency ablation', 'Myomectomy'], 'conditions': ['Uterine Fibroids']}, 'referencesModule': {'references': [{'pmid': '37023398', 'type': 'DERIVED', 'citation': 'Rubio EM, Hilton JF, Bent S, Parvataneni R, Oberman E, Saberi NS, Varon S, Schembri M, Waetjen LE, Jacoby VL. Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids. J Womens Health (Larchmt). 2023 May;32(5):546-552. doi: 10.1089/jwh.2022.0094. Epub 2023 Apr 6.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.ucsf.edu/fibroids', 'label': 'Fibroid Trials at UCSF'}]}, 'descriptionModule': {'briefSummary': "The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa).\n\nThe ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes.\n\nUC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with uterine fibroids who are planning to undergo or have undergone radiofrequency ablation (Acessa) or myomectomy treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planning to undergo or have undergone\\* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids.\n* Able to give informed consent\n* Speak English or Spanish\n\n * Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment\n\nExclusion Criteria:\n\n* \\<21 years of age\n* Plan to undergo hysteroscopic myomectomy'}, 'identificationModule': {'nctId': 'NCT02100904', 'acronym': 'ULTRA Registry', 'briefTitle': 'Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry', 'orgStudyIdInfo': {'id': '14-13325'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women undergoing radiofrequency ablation.', 'description': 'Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).', 'interventionNames': ['Procedure: Radiofrequency ablation of fibroids']}, {'label': 'Women undergoing myomectomy', 'description': 'About 25% of women in the trial will be in the group who receive treatment with myomectomy.', 'interventionNames': ['Procedure: Myomectomy of fibroids']}], 'interventions': [{'name': 'Radiofrequency ablation of fibroids', 'type': 'PROCEDURE', 'armGroupLabels': ['Women undergoing radiofrequency ablation.']}, {'name': 'Myomectomy of fibroids', 'type': 'PROCEDURE', 'armGroupLabels': ['Women undergoing myomectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19904', 'city': 'Dover', 'state': 'Delaware', 'country': 'United States', 'facility': 'Dedicated to Women', 'geoPoint': {'lat': 39.15817, 'lon': -75.52437}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Fibroid and Pelvic Wellness Center of Georgia', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Gynecology Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60430', 'city': 'Homewood', 'state': 'Illinois', 'country': 'United States', 'facility': "Women's Healthcare Associates of IL, SC", 'geoPoint': {'lat': 41.55726, 'lon': -87.6656}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Tassone Advanced Gynecology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'MacArthur Medical Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Acacia OBGYN', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Vanessa Jacoby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}