Trials / Completed
CompletedNCT01647906
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 277 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2012-05-31
- Primary completion
- 2018-09-15
- Completion
- 2018-09-15
- First posted
- 2012-07-24
- Last updated
- 2019-11-25
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01647906. Inclusion in this directory is not an endorsement.