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

NCT ID NCT06554015

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

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.

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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

Coloplast A/S
RECRUITING

Humlebæk, Denmark

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