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New Method for the Collection of the Output From the Ileostoma Using InterPOC

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05891041
Collaborator
(none)
10
Enrollment
1
Location
4.1
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A specially designed, absorbent intestinal tampon would be a discreet solution that addresses current problems with leakage, noise, skin problems, as well as various issues with pinching and ballooning of the ostomy bag. The purpose of this experiment is to rule out that the use of an intestinal tampon is dangerous in humans and to demonstrate that the solution is tolerated to a degree that makes it meaningful to continue the development of the product

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon
    Actual Study Start Date :
    Apr 26, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Aug 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours [6 hours]

      Safety of Interpoc during use

    Secondary Outcome Measures

    1. Pain during interpoc use [6 hours]

      Using the NRS from 0-10

    2. Early warning score during interpoc use [6 hours]

      A low score is better than a high score

    3. Life quality with SF-36 [One time - baseline.]

      High score indicates low quality of life

    4. Life quality with The City of Hope-quality of life - ostomy questionnaire [One time - baseline]

      high score is indicative of low quality of life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet København Ø Hovedstaden Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Michael P Achiam, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Patrick Achiam, DMSCI, associate professor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05891041
    Other Study ID Numbers:
    • H-23000001
    First Posted:
    Jun 6, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 6, 2023