[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06743620":3,"trial-entities:NCT06743620":76,"trial-summary:NCT06743620":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":15,"eligibility_criteria":45,"std_ages":55,"locations":58,"central_contacts":68,"overall_officials":69,"references":74,"see_also_links":75},"NCT06743620","R15-06","Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence","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","ENROLLING_BY_INVITATION","2032-04","2026-07","2026-07-22","2025-04-11","Cook MyoSite","INDUSTRY",false,"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.",null,[19],"Stress Urinary Incontinence",[],"OBSERVATIONAL",[],{"count":24,"type":25},96,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"OTHER","iltamiocel","This is an observational study with no intervention.",[32],"Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel",[34,38],{"measure":35,"description":36,"timeFrame":37},"Long term safety","Long term safety of iltamiocel","5 years",{"measure":39,"description":40,"timeFrame":37},"Long term effectiveness","Long term effectiveness of iltamiocel",[],"FEMALE","18 Years","100 Years",{"inclusion":46,"exclusion":51,"raw_text":54},[47,48,49,50],"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).","Has received at least one dose of iltamiocel as part of the CLBT study.","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.","Has access to a phone or electronic device to allow completion of electronic documents",[52,53],"Has only received placebo as part of the CLBT study.","Unable or unwilling to provide informed consent.","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.",[56,57],"ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"geoPoint":65},"Virtual Site","Harvard","Massachusetts","01451","United States",{"lat":66,"lon":67},42.50009,-71.58284,[],[70],{"name":71,"affiliation":72,"role":73},"Ron Jankowski, PhD","Cook MyoSite, Inc.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":77,"biomarkers":79},[78],"Genuine stress incontinence",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]