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

Coloplast

Status: Enrolling

Conditions: Stoma Ileostomy

Study type: Observational

Funder types: Industry

Identifiers

NCT06554015

CP370

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]