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NCT01625221 · ClinicalTrials.gov registry record · NA
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
A NA study of Fecal Incontinence, sponsored by Torax Medical Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 4
- Study locations
NCT01625221: Completed NA study of Fecal Incontinence, sponsored by Torax Medical Incorporated.
NCT01625221 is a NA study of Fecal Incontinence that has completed, run by Torax Medical Incorporated. The registered enrollment target is 35 participants, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625221, a NA study of Fecal Incontinence, has completed, sponsored by Torax Medical Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).
Primary Outcome
The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.
Conditions Studied
Interventions
- DEVICE Magnetic Anal Sphincter
Study Locations (4)
Other
- Arhus Universitetshospital - Aarhus
- University of Medicine - Nantes
Minnesota
- Colon and Rectal Surgery Associates - Minneapolis
Washington
- Providence Medical Research Center - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-12 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT01625221 record still lists
NCT01625221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 333-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Magnetic Anal Sphincter is the first listed.
NCT01625221 reports a single indexed study location in Other, Minnesota, Washington.
Frequently Asked Questions
What is clinical trial NCT01625221 about?
NCT01625221 is a clinical study titled "Feasibility Study of the Magnetic Anal Sphincter (FENIX System)". The purpose of this feasibility study is to obtain preliminary safety and effectiveness information and develop procedural optimization for the Magnetic Anal Sphincter device (FENIX System) in reinforcement of anal sphincter function to treat severe fecal incontinence (FI).
What is the current status of trial NCT01625221?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2008-12. Estimated completion is 2016-03.
What conditions does trial NCT01625221 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT01625221?
The interventions under investigation include: Magnetic Anal Sphincter (DEVICE).
Who is sponsoring clinical trial NCT01625221?
This trial is sponsored by Torax Medical Incorporated, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01625221 being conducted?
This trial has 4 study locations across Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01625221's enrollment target sits among peer trials
35 14th of 22 higher than 9 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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