Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

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).

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Magnetic Anal Sphincter

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Arhus, Denmark
    • Århus Universitetshospital
• France
  • Nantes, France
    • University of Medicine
• United States
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Colon and Rectal Surgery Associates
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnetic anal sphincter augmentation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Torax Medical Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: FENIX
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 1876, 1990, 2321