FENIX™ Continence Restoration System Registry

Completed

• Conditions: Faecal Incontinence; Fecal Incontinence
• Interventions: Device: FENIX™ Continence Restoration System

• Registration Number: NCT04007250
• Lead Sponsor: Torax Medical Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-07
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Study First Submitted: 2019-06-27
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FENIX participants	FENIX™ Continence Restoration System	Individuals being treated with the FENIX™ Continence Restoration System.

Primary Outcome Measures

Name	Time	Method
Change in fecal incontinence (FI) episodes	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	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	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.	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.

Trial Locations

Locations (2)

University Hospital of Nantes; 🇫🇷 Nantes, France

Kliniken Essen-Mitte; 🇩🇪 Essen, Germany