An Observational Clinical Feasibility Study of The Magnetic Anal Sphincter
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- Torax Medical Incorporated
- Enrollment
- 35
- Locations
- 4
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 60 months
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
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.