FENIX™ Continence Restoration System Registry

NCT04007250 | Completed FDA Device

• 1 other identifier: 3422
• Study Type: observational
• Target: 94
• Locations: 2 countries
• Sites: 2

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.

Conditions

Fecal Incontinence; Faecal Incontinence

Keywords

Magnetic Anal Sphincter Augmentation; FENIX™ continence restoration system; Magnetic Anal Sphincter

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

FENIX participants

Individuals being treated with the FENIX™ Continence Restoration System.

Device: FENIX™ Continence Restoration System

Interventions

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.

Also known as: Magnetic anal sphincter augmentation

FENIX participants

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Torax Medical Incorporated: lead

Study Sites (2)

University Hospital of Nantes

Nantes, France

Location

Kliniken Essen-Mitte

Essen, Germany

Location

MeSH Terms

Conditions

Fecal Incontinence; Encopresis

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: January 7, 2012
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (1)