NCT02456324View on ClinicalTrials.gov

A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

August 31, 2016

Conditions
Anal FistulasRectal Fistulas
Interventions
DEVICE

PICS-AF Device

This is a specialized closure system for anorectal fistulas that is sphincter sparing

DEVICE

Historical Controls Treated with Commercially Available Fistula Plugs

These are patients previously treated with commercially available fistula plugs.

Trial Locations (1)

41013

RECRUITING

Hosptial Universitario VIRGEN DEL ROCIO, Seville

Sponsors

Lead Sponsor

Curaseal Inc.
All Listed Sponsors
lead

Curaseal Inc.

INDUSTRY