Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX

NO_LONGER_AVAILABLE

Conditions studied: Fecal Incontinence

In brief

This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal incontinence. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).

Key facts

Study ID

NCT02722707

Run by

Mayo Clinic

Last updated by the study team

2018-12-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• non-pregnant female patients
• 18 years of age or older with fecal incontinence
• failed conservative therapy ( pelvic floor physical therapy, medications) and failed trial of interstim.

You may not qualify if…

• patients less than 18 years of age,
• pregnant
• previous radiation to pelvis,
• chronic diarrhea or inflammatory bowel disease.

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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