Status:
COMPLETED
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
Lead Sponsor:
Ampa Medical
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output. The main questions it aims to answer are: * Can participants s...
Detailed Description
Study Overview This study aims to evaluate the feasibility and user acceptance of a specialized absorbent intestinal tampon designed to collect ileostomy output. The study seeks to address the limitat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Ileostomy \> 6 months old
- Stoma opening ≥ 10 mm in diameter
- Written informed consent
Exclusion
- Difficulty understanding study information, including language barriers
- Somatic illness, including active inflammatory bowel disease
- Hernia around the stoma
- Daily output \> 2 liters
- Active inflammation in the ileum (diagnosed within 2 months before the study day)
Key Trial Info
Start Date :
December 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06897163
Start Date
December 10 2024
End Date
August 31 2025
Last Update
December 5 2025
Active Locations (1)
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1
Ampa Medical
Copenhagen, Denmark, 1620