FENIX™ Continence Restoration System Registry

Fecal Incontinence Clinical Trial

Official title:

FENIX™ Continence Restoration System Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007250
• Other study ID #: 3422
• Status: Completed
• Start date: January 7, 2012
• Est. completion date: February 27, 2019

Study information

• Verified date: July 2019
• Source: Torax Medical Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Nantes	Nantes
Germany	Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Torax Medical Incorporated

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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]
Primary	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