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

Launched by COLOPLAST A/S · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Heylo™ device, which is designed to help people living with a stoma, such as an ileostomy or colostomy. The Heylo™ system consists of a smartphone app, an adhesive sensor, and a Bluetooth transmitter that work together to notify users when there are changes in their stoma baseplate. This can help reduce leaks and improve overall quality of life for users. Researchers want to understand how effective this device is over time in supporting individuals with stomas.

To participate in this study, you need to be at least 18 years old and currently have an ileostomy or colostomy. If you have used the Heylo™ device for less than seven days, you may also be eligible. However, if you have surgery planned to reverse your stoma in the next six months, you cannot join the trial. Participants will be asked to use the Heylo™ device and provide feedback on their experience, which will help researchers learn more about its long-term benefits.

Gender

ALL

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\]