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Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

NCT01625221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-01-03

Study results available
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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).

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Magnetic Anal Sphincter

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.

Sponsors & Collaborators

  • Torax Medical Incorporated

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-03-31
Completion
2016-03-31

Countries

  • United States
  • Denmark
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625221 on ClinicalTrials.gov