Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 8:19 PM
Study NCT ID:
NCT06153667
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2023-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety', 'timeFrame': '30 days', 'description': 'The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.'}, {'measure': 'Primary Effectiveness', 'timeFrame': '6 months', 'description': 'The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Fibroid']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult women ≥ 18 years with symptomatic uterine fibroid(s).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women ≥ 18 years old at the time of enrollment.\n* Subject has symptomatic uterine fibroid(s), suitable to embolization.\n* Subject provides written informed consent.\n\nExclusion Criteria:\n\n* Subject is pregnant.\n* Subject has suspected pelvic inflammatory disease or any other pelvic infection.\n* Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).'}, 'identificationModule': {'nctId': 'NCT06153667', 'acronym': 'BETTER-UAE', 'briefTitle': 'Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization', 'orgStudyIdInfo': {'id': 'UFE-P4-23-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bearing nsPVA', 'type': 'DEVICE', 'description': 'Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. Bearing nsPVA Embolization Particles are used for the embolization of symptomatic (leiomyoma uteri) uterine fibroids.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Warren Clements, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Alfred Health', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Irene Coughlin', 'role': 'CONTACT', 'email': 'irene.coughlin@merit.com', 'phone': '6175435665'}, {'name': 'Vicky Brunk', 'role': 'CONTACT', 'email': 'vicky.brunk@merit.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}