Trials / Completed
CompletedNCT01110681
Study to Evaluate Solesta for Treatment of Fecal Incontinence
An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2009-11-01
- Completion
- 2010-12-01
- First posted
- 2010-04-27
- Last updated
- 2022-08-26
- Results posted
- 2019-02-28
Locations
15 sites across 7 countries: Canada, Finland, France, Germany, Italy, Norway, Spain
Source: ClinicalTrials.gov record NCT01110681. Inclusion in this directory is not an endorsement.