Gatekeeper for Soiling and Gas Incontinence

CompletedOBSERVATIONAL
Enrollment

13

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

December 31, 2015

Conditions
Gas IncontinenceSoilings, Fecal
Interventions
DEVICE

Gatekeeper

Six polyacrylonitrile prostheses (THD Gatekeeper™ Delivery System, THD SpA, Correggio, Italy) were implanted under 3D-EUS control through a 5mm perianal incision at 1, 3, 5, 7, 9 and 11 o'clock in lithotomy position, and located in the upper-middle intersphincteric space of the anal canal, using a specifically designed system.

All Listed Sponsors
lead

Hospital Mutua de Terrassa

OTHER

NCT05222217 - Gatekeeper for Soiling and Gas Incontinence | Biotech Hunter | Biotech Hunter