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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Faecal Incontinence
• Intervention / Treatment: Device: FENIX™ Continence Restoration System

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • University Hospital of Nantes
• Germany
  • Essen, Germany
    • Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

FENIX participants; Individuals being treated with the FENIX™ Continence Restoration System.

Device: FENIX™ Continence Restoration System; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal incontinence (FI) episodes	Proportion of participants with at least a 50% reduction in FI episodes per week	Evaluate at 6 months and then annually at 12 months through 60 months post implant
Change in fecal incontinence days	Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes	Evaluate at 6 months and then annually at 12 months through 60 months post implant
Adverse events related to the FENIX system	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.	assessed up to last follow up [max 60 months]
Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.	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.	Evaluate at 6 months and then annually at 12 months through 60 months post implant

Collaborators and Investigators

• Sponsor: Torax Medical Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2012
• Primary Completion (Actual): February 27, 2019
• Study Completion (Actual): February 27, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Magnetic Anal Sphincter Augmentation; FENIX™ continence restoration system; Magnetic Anal Sphincter
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 3422 (FDA OOPD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes