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

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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? \[Yes/No\]

Locations
Other Locations
Denmark
Coloplast A/S
RECRUITING
Humlebæk
Contact Information
Primary
Thomas Krarup Simonsen
dktksi@coloplast.com
+4549111873
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-07-02
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Coloplast A/S

This content was sourced from clinicaltrials.gov