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NCT Number: NCT07146035

Feasibility of a Newly Developed Ostomy Prototype

Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life. To overcome this, Coloplast are in the process of developing a leakage measurement device. Each participant will undergo five 24-hour test periods over three weeks, wearing the prototype around the stoma (Test) and on the opposite side (Control).

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Key information

Conditions

Stoma - Ileostomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Has given written informed consent Is at least 18 years old Has full legal capacity Is able (assessed by the investigator) and willing to adhere to study procedures during study duration.

Has had an ileostomy for at least 30 days. Has been self-managing their own ostomy product for at least 14 days. Has experienced leakage under the baseplate at least 3 times within the past 2 weeks.

Is able to fit one of the two test product sizes (Ø50mm or Ø60mm). Uses a flat baseplate Is willing to change their baseplate daily Has intact peristomal skin (assessed by the investigator) Is able to use a smartphone with camera

Exclusion criteria

Is participating in any other clinical investigation during this investigation Has previously participated or completed this investigation Has a known hypersensitivity towards the prototype used in the investigation Is pregnant Is breast feeding Has more than one ostomy synchronously Has ongoing non-healed abdominal wounds Has planned MR scans during the 24-hour test recording

Treatment and study plan

CP369 Feasibility of a newly developed ostomy prototype (only one intervention)

Device

The study is an open-label, single-arm, comparative study, investigating the feasibility of the prototype in subjects with ileostomy. The study is comparing the prototype exposed only to sweat (abdominal side) with the prototype exposed to sweat and output (peristomal side). Meaning, subjects are their own control.

Primary outcomes

  1. To test the system performance of the prototype.

    Time frame: 3 weeks from enrollment to end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Krarup Simonsen

CONTACT

[email protected]

+4549111873

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

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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