Feasibility Study of the Magnetic Anal Sphincter (FENIX System)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Torax Medical Incorporated
ClinicalTrials.gov Identifier:
NCT01625221
First received: June 19, 2012
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Fecal Incontinence
Device: Magnetic Anal Sphincter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter

Resource links provided by NLM:


Further study details as provided by Torax Medical Incorporated:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Reduction in Fecal Incontinence Symptoms [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: December 2008
Estimated Study Completion Date: March 2016
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625221

Locations
United States, Minnesota
Colon and Rectal Surgery Associates
Minneapolis, Minnesota, United States
United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204
Denmark
Arhus Universitetshospital
Arhus, Denmark
France
University of Medicine
Nantes, France
Sponsors and Collaborators
Torax Medical Incorporated
  More Information

No publications provided

Responsible Party: Torax Medical Incorporated
ClinicalTrials.gov Identifier: NCT01625221     History of Changes
Other Study ID Numbers: 1876, 1990, 2321
Study First Received: June 19, 2012
Results First Received: November 26, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
Denmark: States Agency of Medicines
France: National Agency for the Safety of Medicine and Health Products

Keywords provided by Torax Medical Incorporated:
FENIX

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 11, 2014