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Prospective Longitudinal Study of Heylo™ for People Living With a Stoma

Recruitingn/aAges 18 Years - anyAllColoplast A/S
NCT06554015 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Coloplast A/S
Humlebæk, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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