NCT02722707

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

First QC Date

February 26, 2016

Last Update Submit

December 27, 2018

Conditions

Fecal Incontinence

Interventions

magnetic anal sphincter augmentation for fecal incontinenceDEVICE

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

Also known as: FENIX

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-pregnant female patients
  • years of age or older with fecal incontinence
  • failed conservative therapy ( pelvic floor physical therapy, medications) and failed trial of interstim.

You may not qualify if:

  • patients less than 18 years of age,
  • pregnant
  • previous radiation to pelvis,
  • chronic diarrhea or inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Paul D Pettit, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gyn Surgery

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 30, 2016

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

US(2)