Trials / Terminated
TerminatedNCT00762047
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Carbon Medical Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Durasphere FI | Durasphere Injection |
| DEVICE | Sham | Sham injection with anesthesia |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2008-08-01
- Completion
- 2009-06-01
- First posted
- 2008-09-30
- Last updated
- 2013-07-30
Source: ClinicalTrials.gov record NCT00762047. Inclusion in this directory is not an endorsement.