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Do Prostheses of SphinkeeperTM Migrate After Operation?

NCT04992429 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2023-01-18

No results posted yet for this study

Summary

32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

Conditions

  • Fecal Incontinence

Interventions

PROCEDURE

SphinkeeperTM

The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile)

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
2020-06-01
Primary Completion
2021-06-18
Completion
2021-06-18

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 NCT04992429 on ClinicalTrials.gov