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Enrolling By InvitationNCT06743620

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

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
96 (estimated)
Sponsor
Cook MyoSite · Industry
Sex
Female
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERiltamiocelThis is an observational study with no intervention.

Timeline

Start date
2025-04-11
Primary completion
2032-04-01
Completion
2032-04-01
First posted
2024-12-20
Last updated
2025-04-29

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06743620. Inclusion in this directory is not an endorsement.

Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress In (NCT06743620) · Clinical Trials Directory