NCT02722707

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

Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX. A Humanitarian Use Device ( HUD), Which Has Recently Received a Humanitarian Device Exemption (HDE) From the Food and Drug Administration ( FDA)

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The FENIX is surgically placed. This surgery could be an outpatient procedure or at most an overnight stay in the hospital. The design of the device allows it to be effective immediately. The device is similar to the LINX device used for esophageal reflux. It is a circular set of magnets which surrounds the ano-rectal support. The size of the device is determined at the time of surgery so that the ano-rectum is closed. When the patient strains at stool, this pressure separates the magnets and allows passage of stool. The magnets are held together by an independent malleable titanium wire. Once straining at stool stops, the magnets are able to re-connect or close the rectum. We will monitor patients for postoperative complications related to surgery.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	magnetic anal sphincter augmentation for fecal incontinence	Surgical placement of HUD called FENIX for female patients that have failed conservative therapy and less invasive therapies or who are not candidates for such therapies

Timeline

• First posted: 2016-03-30
• Last updated: 2018-12-31

Locations

2 sites across 1 country: United States