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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05891041
Other study ID # H-23000001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 26, 2023
Est. completion date October 1, 2023

Study information

Verified date December 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 1, 2023
Est. primary completion date September 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Rigshospitalet København Ø Hovedstaden

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours Safety of Interpoc during use 6 hours
Secondary Pain during interpoc use Using the NRS from 0-10 6 hours
Secondary 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 6 hours
Secondary Scale (0-10) score of Discomfort, acid reflux, nausea A low score is better than a high score 6 hours
Secondary InterPoc™ weight before and after insertion For comparable 6 hours
Secondary Leakage around the stoma pouch Scale: 1-3) 6 hours
Secondary Fecal output in stoma bag (ml) before and after the trail scale 1-3 6 hours
Secondary InterPoc™ Skin Irritation (Scale: 1-3) 6 hour
Secondary Insertion and removal resistance scale 1-3) 6 hour
Secondary Food consumption descriptive 6 hour
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