Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX
| Status: | No longer available |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/2/2019 |
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)
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).
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).
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- patients less than 18 years of age,
- pregnant
- previous radiation to pelvis,
- chronic diarrhea or inflammatory bowel disease.
We found this trial at
2
sites
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