Ileostomy - Stoma Clinical Trial
Official title:
First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc
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 |
Verified date | December 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | København Ø | Hovedstaden |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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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