FENIX™ Continence Restoration System Registry

Torax Medical

Status: Completed

Conditions: Faecal Incontinence; Fecal Incontinence

Treatments: Device: FENIX™ Continence Restoration System

Study type: Observational

Funder types: Industry

Identifiers

NCT04007250

3422 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

94 participants in 1 patient group

FENIX participants

Description:

Individuals being treated with the FENIX™ Continence Restoration System.

Treatment:

Device: FENIX™ Continence Restoration System