NCT04007250

FENIX™ Continence Restoration System Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Torax Medical Incorporated · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-07
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2019-07-05
• Last updated: 2019-07-26

Locations

2 sites across 2 countries: France, Germany

Regulatory

• FDA-regulated device study