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NCT01893138 · ClinicalTrials.gov registry record · Phase 3
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
A Phase 3 study, sponsored by Cook MyoSite.
- Completed
- Registry status
- Phase 3
- Development phase
- 311
- Enrollment target
NCT01893138: Completed Phase 3 study, sponsored by Cook MyoSite.
NCT01893138 is a Phase 3 study that has completed, run by Cook MyoSite. The registered enrollment target is 311 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893138, a Phase 3 study, has completed, sponsored by Cook MyoSite.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 311 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Interventions
- OTHER Placebo
- BIOLOGICAL Iltamiocel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2013-11-21 |
| Est. Completion | 2020-11-10 |
| Phase | Phase 3 |
What the finished NCT01893138 record still lists
NCT01893138 is an interventional study that assigns participants to a tested intervention. The registered 311 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01893138 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893138 about?
NCT01893138 is a clinical study titled "Autologous Muscle Derived Cells for Female Urinary Sphincter Repair". This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence...
What is the current status of trial NCT01893138?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 311 participants. The study started on 2013-11-21. Estimated completion is 2020-11-10.
What interventions are being tested in trial NCT01893138?
The interventions under investigation include: Placebo (OTHER), Iltamiocel (BIOLOGICAL).
Who is sponsoring clinical trial NCT01893138?
This trial is sponsored by Cook MyoSite, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01893138's enrollment target sits among peer trials
311 1106th of 2000 higher than 894 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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