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New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon

Ileostomy - Stoma Clinical Trial

Official title:
First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc

Clinical Trial Summary

1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies. Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.

Clinical Trial Description

Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon. The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05891041
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase
Start date April 26, 2023
Completion date October 1, 2023
View Details
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