Overview

This trial is active, not recruiting.

Condition fecal incontinence
Treatment magnetic anal sphincter
Sponsor Torax Medical Incorporated
Start date December 2008
End date March 2012
Trial size 35 participants
Trial identifier NCT01625221, 1876, 1990, 2321

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.

Primary Outcomes

Measure
Serious Adverse Events
time frame: 12 months
Reduction in Fecal Incontinence Symptoms
time frame: 12 Months

Eligibility Criteria

Male or female participants from 19 years up to 84 years old.

Inclusion Criteria: - Age ≥ 19 years, <85 years, life expectancy >3yrs. - Documented history of severe fecal incontinence for at least 6 months - Subject diary documents ≥ 2 episodes per week on average over diary period, leakage greater than seepage - Subject has failed standard conservative and medical therapy - Subject is a surgical candidate. - Subject is willing and able to cooperate with follow-up examinations. - Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes. Exclusion Criteria: - Subject has history of significant obstructed defecation or other significant chronic defecatory motility disorders - Subject has current, external full thickness rectal prolapse or vaginal prolapse - Subject has an electric or metallic implant within 10cm of the area of device placement - Subject has Inflammatory Bowel Disease - Subject has Irritable Bowel Syndrome - Subject has systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's) - Subject has active pelvic infection - Subject has chronic diarrhea - Subject diagnosed with anal, rectal, or colon cancer within 2 years - Subject has had prior anterior resection of the rectum - Subject has undergone pelvic radiation therapy - Subject has significant scarring of the recto-vaginal septum, a permanent implant in the recto-vaginal septum, or a history of recto-vaginal fistula - Subject has had previous anorectal posterior compartment surgery - The procedure is an emergency procedure - Subject is currently being treated with another investigational drug or investigational device. - Subject cannot understand trial requirements or is unable to comply with follow-up schedule. - Subject is pregnant or nursing, or plans to become pregnant. - Subject has history of complex anal fistula

Additional Information

Official title An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Torax Medical Incorporated.