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NCT01647906 · ClinicalTrials.gov registry record
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
A clinical trial, sponsored by Bausch Health Americas.
- Completed
- Registry status
- 277
- Enrollment target
NCT01647906: Completed study, sponsored by Bausch Health Americas.
NCT01647906 is a clinical trial that has completed, run by Bausch Health Americas. The registered enrollment target is 277 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647906 has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- 277 participants
- Enrollment target
Study Summary
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
Primary Outcome
The primary effectiveness endpoint is freedom from Fecal Incontinence Reintervention. Patients will be evaluated at 3, 6, 12, 24, and 36 months after the last Solesta treatment for the occurrence (or lack of occurrence) of Fecal Incontinence Reintervention. Fecal Incontinence Reintervention includes Fecal Incontinence treatment of sphincteroplasty, implantation of artificial bowel sphincter, retreatment with Solesta, graciloplasty, sacral nerve stimulation (SNS) or other surgical interventions t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2012-05-31 |
| Est. Completion | 2018-09-15 |
What the finished NCT01647906 record still lists
NCT01647906 is an observational study that tracks outcomes without assigning an intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01647906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01647906 about?
NCT01647906 is a clinical study titled "Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)". The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
What is the current status of trial NCT01647906?
This trial is currently completed. The enrollment target is 277 participants. The study started on 2012-05-31. Estimated completion is 2018-09-15.
Who is sponsoring clinical trial NCT01647906?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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