Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Torax Medical Incorporated
Study subjects followed to 12 months post implant outside the U.S. Study subjects followed to 5 years post implant in the U.S.
Age
19–84
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
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
Clareo Health | Feasibility Study of the Magnetic Anal Sphincter (FENIX System)
