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SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

NCT04664868 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2020-12-11

No results posted yet for this study

Summary

Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.

Conditions

  • Faecal Incontinence

Interventions

PROCEDURE

Sphinkeeper™

Sphinkeeper™ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Stefan Riss, Prof.MD · Medical University of Vienna, Head of Pelvic Floor surgery

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-11-01
Completion
2020-07-01

Countries

  • Austria

Study Locations

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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 NCT04664868 on ClinicalTrials.gov