Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-su… (NCT06743620) | Clinical Trial Compass
By InvitationNot Applicable
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
United States96 participantsStarted 2025-04-11
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Has only received placebo as part of the CLBT study.
* Unable or unwilling to provide informed consent.