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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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

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Fecal Incontinence

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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FENIX

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Paul D Pettit

Consultant Gyn Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul D Pettit, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Mayo Clinic in Rochester

Rochester, Minnesota, United States