Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06743620
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-29
First Post:
2024-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04661293', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety', 'timeFrame': '5 years', 'description': 'Long term safety of iltamiocel'}, {'measure': 'Long term effectiveness', 'timeFrame': '5 years', 'description': 'Long term effectiveness of iltamiocel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female subjects who have received iltamiocel as part of participation in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment will be considered for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).\n* Has received at least one dose of iltamiocel as part of the CLBT study.\n* Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.\n* Has access to a phone or electronic device to allow completion of electronic documents\n\nExclusion Criteria:\n\n* Has only received placebo as part of the CLBT study.\n* Unable or unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06743620', 'acronym': 'CLBT RGST', 'briefTitle': 'Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook MyoSite'}, 'officialTitle': 'Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of Cook Myosite, Inc. Sponsored CELLEBRATE Clinical Study in Patients With Persistent or Recurrent Stress Urinary Incontinence (SUI) Following Surgical Treatment', 'orgStudyIdInfo': {'id': 'R15-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel', 'interventionNames': ['Other: iltamiocel']}], 'interventions': [{'name': 'iltamiocel', 'type': 'OTHER', 'description': 'This is an observational study with no intervention.', 'armGroupLabels': ['Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01451', 'city': 'Harvard', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Virtual Site', 'geoPoint': {'lat': 42.50009, 'lon': -71.58284}}], 'overallOfficials': [{'name': 'Ron Jankowski, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cook MyoSite, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook MyoSite', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}