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Completed

NCT Number: NCT05891041

New Method for the Collection of the Output From the Ileostoma Using a Intestinal Tampon

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.

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Key information

Conditions

Ileostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

København Ø, Capital Region, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 hours

    Safety of Interpoc during use

Secondary outcomes

  1. Pain during interpoc use

    Time frame: 6 hours

    Using the NRS from 0-10

  2. Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),

    Time frame: 6 hours

    A low score is better than a high score

  3. Scale (0-10) score of Discomfort, acid reflux, nausea

    Time frame: 6 hours

    A low score is better than a high score

  4. InterPoc™ weight before and after insertion

    Time frame: 6 hours

    For comparable

  5. Leakage around the stoma pouch

    Time frame: 6 hours

    Scale: 1-3)

  6. Fecal output in stoma bag (ml) before and after the trail

    Time frame: 6 hours

    scale 1-3

  7. InterPoc™ Skin Irritation

    Time frame: 6 hour

    (Scale: 1-3)

  8. Insertion and removal resistance

    Time frame: 6 hour

    scale 1-3)

  9. Food consumption

    Time frame: 6 hour

    descriptive

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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