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.
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 Type
OBSERVATIONAL
Enrollment
24
Rigshospitalet
København Ø, Capital Region, Denmark
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
Safety of Interpoc during use
Time frame: 6 hours
Pain during interpoc use
Using the NRS from 0-10
Time frame: 6 hours
Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),
A low score is better than a high score
Time frame: 6 hours
Scale (0-10) score of Discomfort, acid reflux, nausea
A low score is better than a high score
Time frame: 6 hours
InterPoc™ weight before and after insertion
For comparable
Time frame: 6 hours
Leakage around the stoma pouch
Scale: 1-3)
Time frame: 6 hours
Fecal output in stoma bag (ml) before and after the trail
scale 1-3
Time frame: 6 hours
InterPoc™ Skin Irritation
(Scale: 1-3)
Time frame: 6 hour
Insertion and removal resistance
scale 1-3)
Time frame: 6 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Food consumption
descriptive
Time frame: 6 hour