FENIX™ Continence Restoration System Registry

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.

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Key information

Conditions

Fecal Incontinence Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Faecal Incontinence Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Nantes, Nantes, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals being treated with the FENIX™ Continence Restoration System
Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.

Exclusion criteria

Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy <5 years)

Treatment and study plan

FENIX™ Continence Restoration System

Device

The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence.

The FENIX™ System is comprised of the following components:

FENIX™ System Implant
FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed.

Other names: Magnetic anal sphincter augmentation

Primary outcomes

Change in fecal incontinence (FI) episodes

Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant

Proportion of participants with at least a 50% reduction in FI episodes per week
Change in fecal incontinence days

Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant

Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes
Adverse events related to the FENIX system

Time frame: assessed up to last follow up [max 60 months]

From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately.
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.

Time frame: Evaluate at 6 months and then annually at 12 months through 60 months post implant
Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales:
- Lifestyle (10 items)
- Coping/Behavior (9 items)
- Depression/Self Perception (7 items)
- Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a "composite" or total score but always presented individually.

Sponsors and collaborators

Lead sponsor

Torax Medical Incorporated

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2019
First posted: Jul 5, 2019
Registry last updated: Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed