Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

NCT ID: NCT01625221

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Fecal Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Magnetic Anal Sphincter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torax Medical Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Denmark; France

Other Identifiers

1876, 1990, 2321

Identifier Type: -

Identifier Source: org_study_id