A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Coloplast A/S
No Placebo Group
Trial Summary
What is the purpose of this trial?
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.
Research Team
TB
Thais Benjamin N. Christensen, M.Sc. (BME)
Principal Investigator
Coloplast A/S
Eligibility Criteria
Inclusion Criteria
The subject is at least 18 years of age
The subject has fecal incontinence
Treatment Details
Interventions
- Fecal Incontinence Management System (Device)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fecal Incontinence management systemExperimental Treatment1 Intervention
Fecal Incontinence Management System is based on the same principle as fecal pouches. A barrier around anus to ensure adhesion and prevent leakage.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Coloplast A/S
Lead Sponsor
Trials
155
Recruited
14,800+
Founded
1957
Headquarters
Humlebæk, Denmark
Known For
Intimate Healthcare Solutions
Top Products
Ostomy bags, Continence products, Wound dressings
Kristian Villumsen
Coloplast A/S
Chief Executive Officer since 2018
Master's degree in Political Science from Aarhus University
Preeti Jain
Coloplast A/S
Chief Medical Officer since 2023
MD from University of Copenhagen