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Gatekeeper for Soiling and Gas Incontinence

NCT05222217 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2022-02-03

No results posted yet for this study

Summary

Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined.

The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before.

Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses

Conditions

  • Gas Incontinence
  • Soilings, 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.

Sponsors & Collaborators

  • Hospital Mutua de Terrassa

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-11-30
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222217 on ClinicalTrials.gov