New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon
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About
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.
Full 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.
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Inclusion criteria
- Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm
Exclusion criteria
Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters
Trial contacts and locations
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Central trial contact
Mohamed Jimale, Medical student; Michael Achiam, DMSCI
Data sourced from clinicaltrials.gov
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