CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Magnetic Anal Sphincterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01625221
NCT01625221N/ACompleted
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An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

Torax Medical Incorporated·interventional·Posted Jun 21, 2012·Updated Jan 3, 2018

In Brief

A clinical study evaluating Magnetic Anal Sphincter for Fecal Incontinence. Completed, enrolled 35 participants across 4 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesDenmark, France, United States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2012
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2012
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.0 years ago

Interventions

Magnetic Anal Sphincterdevice

The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.