Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Magnetic anal sphincter augmentation	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 Outcome Measures

Name	Time	Method
Adverse Events	60 months	The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.
Reduction in Fecal Incontinence Symptoms	12 Months	Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.

Secondary Outcome Measures

Name	Time	Method

Locations (4): Colon and Rectal Surgery Associates
🇺🇸
Minneapolis, Minnesota, United States
Arhus Universitetshospital
🇩🇰
Arhus, Denmark
University of Medicine
🇫🇷
Nantes, France
Providence Medical Research Center
🇺🇸
Spokane, Washington, United States