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Clinical Trial Summary

1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPocâ„¢, 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 InterPocâ„¢, 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


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

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