NCT01625221

Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Torax Medical Incorporated · Industry
• Sex: All
• Age: 19 Years – 84 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-03-01
• Completion: 2016-03-01
• First posted: 2012-06-21
• Last updated: 2018-01-03
• Results posted: 2014-01-13

Locations

4 sites across 3 countries: United States, Denmark, France