Status:
RECRUITING
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
Lead Sponsor:
Coloplast A/S
Conditions:
Stoma Ileostomy
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Are you at least 18 years old? \[Yes/No\]
- Do you have an ileostomy or a colostomy? \[Yes/No\]
- Have you used Heylo™ for less than seven days? \[Yes/No\]
Exclusion
- 1\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 2 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06554015
Start Date
July 1 2024
End Date
July 2 2027
Last Update
September 4 2025
Active Locations (1)
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1
Coloplast A/S
Humlebæk, Denmark