Last reviewed · How we verify
NCT01647906: SoFI
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
trial in Fecal Incontinence in 277 participants. Completed in 15 September 2018.
15 September 2018
Quick facts
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 277 |
| Start date | 31 May 2012 |
| Primary completion | 15 September 2018 |
| Estimated completion | 15 September 2018 |
| Sites | 20 locations across United States |
Conditions studied
- Fecal Incontinence — all drugs for Fecal Incontinence →
Sponsor
Bausch Health Americas, Inc. — full company profile →
Who can join
18 and older, any sex, with Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up.
Quiroz LH, Galliano DE, da Silva G, Carmichael JC, et al · · 2023 · cited 2× · PMID 35001051 · DOI 10.1097/dcr.0000000000002348
Verify or expand the search:
- PubMed search for NCT01647906
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Bausch Health Americas, Inc. trials
Trials by the same sponsor.
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- NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
- NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
- NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01647906 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bausch Health Americas, Inc.
- Last refreshed: 25 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01647906.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing