Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
Public ClinicalTrials.gov record NCT01647906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01647906
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 277 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2012 (Actual)
- Primary completion
- Sep 15, 2018 (Actual)
- Completion
- Sep 15, 2018 (Actual)
- Last update posted
- Nov 25, 2019
2012 – 2018
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Colon and Rectal Medical Services | Los Angeles | California | 90048 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| Galliano Private Practice | Port Charlotte | Florida | 33948 | — |
| USF Health | Tampa | Florida | 33606 | — |
| North Pinellas Surgical Institute | Tarpon Springs | Florida | 34689 | — |
| Cleveland Clinic Florida Health | Weston | Florida | 33331 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Georgia Regents Research Institute | Augusta | Georgia | 30912 | — |
| The Iowa Clinic | Des Moines | Iowa | 50266 | — |
| Colon and Rectal Surgery Associates, Ltd. | Minneapolis | Minnesota | 55407 | — |
| Colon and Rectal Surgery, LLC | Omaha | Nebraska | 68114 | — |
| North Shore Long Island Jewish Health Systems | Huntington | New York | 11743 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Cleveland Clinic Foundation Digestive Disease Institute | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Colon and Rectal Research Foundation | Allentown | Pennsylvania | 18103 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05446 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01647906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 25, 2019 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01647906 live on ClinicalTrials.gov.