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

NCT02722707 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2018-12-31

No results posted yet for this study

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).

Conditions

  • Fecal Incontinence

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Paul D Pettit, MD · Mayo Clinic

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722707 on ClinicalTrials.gov