N/A
N=35
Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01625221 ↗Enrolled (actual)
35
Serious AEs
17.1%
Results posted
Jan 2014
Primary outcome: Primary: Adverse Events — 223; 7 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic Anal Sphincter (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Torax Medical Incorporated
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
223; 7 | — |
| PRIMARY Reduction in Fecal Incontinence Symptoms |
3.8 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Age ≥ 19 years, 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
Data sourced from ClinicalTrials.gov (NCT01625221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.