Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

Completed · Not applicable

Conditions studied: Fecal Incontinence

In brief

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).

Key facts

Study ID

NCT01625221

Run by

Torax Medical Incorporated

People needed

35

Starts

2008-12-01

Expected to finish

2016-03-01

Last updated by the study team

2018-01-03

Who can join

Age: 19 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Colon and Rectal Surgery Associates — Minneapolis, Minnesota, United States
• Providence Medical Research Center — Spokane, Washington, United States
• Arhus Universitetshospital — Aarhus, Denmark
• University of Medicine — Nantes, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.