Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

Fecal Incontinence Clinical Trial

Official title:

An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625221
• Other study ID #: 1876, 1990, 2321
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: December 7, 2017
• Start date: December 2008
• Est. completion date: March 2016

Study information

• Verified date: December 2017
• Source: Torax Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 84 Years

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

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.

Locations

Country	Name	City	State
Denmark	Arhus Universitetshospital	Arhus
France	University of Medicine	Nantes
United States	Colon and Rectal Surgery Associates	Minneapolis	Minnesota
United States	Providence Medical Research Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Torax Medical Incorporated

Countries where clinical trial is conducted

United States,  Denmark,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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