Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Recruiting
Observational Study
Stoma Ileostomy
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Coloplast A/S · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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\]
Contacts