Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

NCT01625221 | Completed Results

• 1 other identifier: 1876, 1990, 2321
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 4

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).

Conditions

Fecal Incontinence

Keywords

FENIX

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Magnetic anal sphincter augmentation

EXPERIMENTAL

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

Interventions

Magnetic Anal Sphincter 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.

Magnetic anal sphincter augmentation

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torax Medical Incorporated: lead

Study Sites (4)

Colon and Rectal Surgery Associates

Minneapolis, Minnesota, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

Arhus Universitetshospital

Aarhus, Denmark

Location

University of Medicine

Nantes, France

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: VP of Clinical Affairs
• Organization: Torax Medical, Inc.

aderosier@toraxmedical.com

651-361-8900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: December 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2016
• Last Updated: January 3, 2018
• Results First Posted: January 13, 2014

Record last verified: 2017-12

Locations

US (2); FR (1); DK (1)