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New smart patch could warn stoma users of leaks before they happen

NCT ID NCT06554015

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing Heylo™, a digital system that alerts people with a stoma when their baseplate is about to leak. The system includes a smartphone app, a sensor, and a Bluetooth transmitter. Researchers will follow 100 adults with an ileostomy or colostomy for 12 months to see if it improves quality of life and reduces leakage worries.

What this could mean

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

Active substance
Heylo™ digital leakage notification system (smartphone app, adhesive sensor, Bluetooth transmitter)
What this could lead to
If successful, Heylo™ could help people with a stoma feel more confident and reduce leakage-related distress, improving daily quality of life.
What could go wrong
This is an early observational study with only 100 participants and no control group, so results may not apply to everyone. The device may not prevent all leaks or work for all stoma types.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

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.

Who is studied

Outside this investigation, stoma patients eligible for the Heylo™ device prescription, will be onboarded to Heylo™ by stoma care nurses. Subjects for this study will be identified through their Heylo™ app activation. A minimum of 100 subjects will be enrolled.

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: 1. Are you at least 18 years old? \[Yes/No\] 2. Do you have an ileostomy or a colostomy? \[Yes/No\] 3. Have you used Heylo™ for less than seven days? \[Yes/No\] Exclusion Criteria: 1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]

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As listed by the trial registrant

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

Stoma ileostomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Coloplast A/S

    RECRUITING

    Humlebæk, Denmark

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