10
Participants
Start Date
December 10, 2024
Primary Completion Date
September 30, 2025
Study Completion Date
November 30, 2025
Specialized Absorbent Intestinal Tampon
The specialized absorbent intestinal tampon is designed to be self-inserted by participants with ileostomies. It aims to collect ileostomy output and improve the quality of life by reducing complications associated with traditional stoma bags. The study will test different tampon designs and coatings to find the most suitable one for insertion and retention. Participants will be observed and interviewed during the insertion process, and their feedback on discomfort or pain will be collected using a numerical rating scale (NRS). Stool samples will be collected before and after tampon use for microbiota analysis.
Ampa Medical, Copenhagen
Lead Sponsor
Ampa Medical
INDUSTRY