Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

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

Official Title
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An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Magnetic Anal Sphincter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic anal sphincter augmentation<br>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. | Device: Magnetic Anal Sphincter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | 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. | 60 months | 
| Reduction in Fecal Incontinence Symptoms | 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. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FENIX