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

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ClinicalTrials.gov Identifier: NCT02722707
Expanded Access Status : No longer available
First Posted : March 30, 2016
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Paul D Pettit, Mayo Clinic

Brief 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).

Condition or disease Intervention/treatment
Fecal Incontinence Device: magnetic anal sphincter augmentation for fecal incontinence

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.

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Study Type : Expanded Access
Official Title: 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)

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement


Intervention Details:
  • 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
    Other Name: FENIX

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722707


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Paul D Pettit, MD Mayo Clinic

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Responsible Party: Paul D Pettit, Consultant Gyn Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02722707     History of Changes
Other Study ID Numbers: 16-000150
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases