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New baseplate could soothe stoma skin woes

NCT ID NCT07316530

Symptom relief Sponsor: Coloplast A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This small study tested a newly developed ostomy baseplate designed to better protect the skin around a stoma. Thirteen people with ileostomies tried both the new baseplate and a standard one for 6 hours each. The main goal was to see if the new baseplate reduced itching between 4 and 6 hours after application.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ostomy baseplate (medical device)
What this could lead to
If it works, this could lead to a better baseplate that reduces skin irritation and itching for people with ileostomies.
What could go wrong
This is a very small, early exploratory study with only 13 participants, so results may not apply to everyone. The device only aims to ease symptoms, not cure the underlying condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

13 people

The number who actually took part.

Started

Nov 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has given written informed consent * Is at least 18 years old * Has full legal capacity * Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale). * Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days before the inclusion. * Has had the stoma for at least 90 days * Has a stoma size less than 45mm in diameter * Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days * Has suitable peristomal skin area (assessed by investigator) to participate in investigation * Is willing to refrain from analgesics within 24 hours before the test days * Is willing to refrain from antihistamine within 96 hours before the test days * Is willing to refrain from steroid treatment within 24 hours before the test days Exclusion Criteria: * Is currently receiving or have within the past 60 days received radio-and/or chemotherapy. * low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer. * Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray. * Is breastfeeding * Is pregnant based on urine pregnancy test. * Has known hypersensitivity towards any of the devices used in the investigation. * Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stoma ileostomy

Contacts and locations

Locations

  • Thomas Krarup Simonsen

    Humlebæk, Denmark

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