Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX
Primary Purpose
Fecal Incontinence
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
magnetic anal sphincter augmentation for fecal incontinence
Sponsored by
About this trial
This is an expanded access trial for Fecal Incontinence
Eligibility 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.
Sites / Locations
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02722707
Brief Title
Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX
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)
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
magnetic anal sphincter augmentation for fecal incontinence
Other Intervention Name(s)
FENIX
Intervention Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D Pettit, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX
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