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Clinical trial

A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

NCT05776277 is registered in ClinicalTrials.gov with Cook MyoSite as lead sponsor.

NCT NCT05776277
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Registry record

As filed in ClinicalTrials.gov.

Title
A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)
Lead sponsor
Cook MyoSite
Phase
Phase 3
Overall status
Active, not recruiting
Start date
March 21, 2024
Completion date
December 31, 2027
Enrollment
200 (estimated)
Sites
25

Conditions

As the registry lists them; a condition with its own page is linked.

fecal incontinence