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The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.
Age
All ages
Sex
ALL
Healthy Volunteers
No
University Hospital of Nantes
Nantes, France
Kliniken Essen-Mitte
Essen, Germany
Start Date
January 7, 2012
Primary Completion Date
February 27, 2019
Completion Date
February 27, 2019
Last Updated
July 26, 2019
94
ACTUAL participants
FENIX™ Continence Restoration System
DEVICE
Lead Sponsor
Torax Medical Incorporated
NCT05626816
NCT06532123
NCT03825575
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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