Last reviewed · How we verify
NCT04007250
FENIX™ Continence Restoration System Registry
trial testing FENIX™ Continence Restoration System in Fecal Incontinence in 94 participants. Completed in 27 February 2019.
27 February 2019
Quick facts
| Lead sponsor | Torax Medical Incorporated |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 94 |
| Start date | 7 January 2012 |
| Primary completion | 27 February 2019 |
| Estimated completion | 27 February 2019 |
| Sites | 2 locations across France, Germany |
Drugs / interventions tested
- FENIX™ Continence Restoration System
Conditions studied
- Fecal Incontinence — all drugs for Fecal Incontinence →
- Faecal Incontinence — all drugs for Faecal Incontinence →
Sponsor
Torax Medical Incorporated
Who can join
Eligibility, any sex, with Fecal Incontinence or Faecal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04007250
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06562140 — Multidimensional Examination of Patients with Colorectal and Anal Cancer · recruiting
- NCT06273046 — Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback · NA · recruiting
Other Torax Medical Incorporated trials
Trials by the same sponsor.
- NCT02429830 — LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy · NA · completed
- NCT01940185 — A Post-Approval Study of the LINX® Reflux Management System · completed
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 NCT04007250 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Torax Medical Incorporated
- Last refreshed: 26 July 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/NCT04007250.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing