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NCT04992429

Do Prostheses of SphinkeeperTM Migrate After Operation?

Completed Last updated 18 January 2023
What this trial tests

trial testing SphinkeeperTM in Fecal Incontinence in 32 participants. Completed in 18 June 2021.

Timeline
1 June 2020
Primary endpoint
18 June 2021
18 June 2021

Quick facts

Lead sponsorMedical University of Vienna
StatusCompleted
Study typeOBSERVATIONAL
Enrollment32
Start date1 June 2020
Primary completion18 June 2021
Estimated completion18 June 2021
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 90, any sex, with Fecal Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Endosonographic monitoring of Sphinkeeper<sup>®</sup> prostheses movements: does physical activity have an impact?
    Dawoud C, Gidl D, Widmann KM, Pereyra D, et al · · 2024 · cited 3× · PMID 37640968 · DOI 10.1007/s13304-023-01636-y
  2. Long-term outcome after SphinKeeper® surgery for treating fecal incontinence-who are good candidates?
    Dawoud C, Widmann KM, Pereyra D, Harpain F, et al · · 2023 · cited 2× · PMID 38052934 · DOI 10.1007/s00423-023-03188-6

Verify or expand the search:

Other recruiting trials for Fecal Incontinence

Currently open trials in the same condition.

Other Medical University of Vienna trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04992429.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing