Status:
COMPLETED
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Lead Sponsor:
Medical University of Vienna
Conditions:
Faecal Incontinence
Eligibility:
All Genders
18-90 years
Brief 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...
Detailed Description
The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeepe...
Eligibility Criteria
Inclusion
- Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
- Ability and willingness to understand and comply with study interventions and restrictions.
- Voluntarily signed informed consent after full explanation of the study to the participant.
Exclusion
- Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
- Inability to communicate well with the investigator due to language problems or reduced mental development
- Inability or unwillingness to give written informed consent
Key Trial Info
Start Date :
August 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04664868
Start Date
August 1 2018
End Date
July 1 2020
Last Update
December 11 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090