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NCT04664868

SphinkeeperTM Procedure for Treating Severe Faecal Incontinence

Completed Last updated 11 December 2020
What this trial tests

trial testing Sphinkeeper™ in Faecal Incontinence in 11 participants. Completed in 1 July 2020.

Timeline
1 August 2018
Primary endpoint
1 November 2019
1 July 2020

Quick facts

Lead sponsorMedical University of Vienna
StatusCompleted
Study typeOBSERVATIONAL
Enrollment11
Start date1 August 2018
Primary completion1 November 2019
Estimated completion1 July 2020
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Vienna

Who can join

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

Sponsor's own description

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.

Publications & conference data

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

  1. Sphinkeeper Procedure for Treating Severe Faecal Incontinence-A Prospective Cohort Study.
    Dawoud C, Bender L, Widmann KM, Harpain F, et al · · 2021 · cited 8× · PMID 34768486 · DOI 10.3390/jcm10214965
  2. Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review.
    Gassner L, Wild C, Walter M. · · 2022 · cited 5× · PMID 35978293 · DOI 10.1186/s12876-022-02441-4

Verify or expand the search:

Other recruiting trials for Faecal 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/NCT04664868.

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