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

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

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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]

Study details
    Stoma Ileostomy

NCT06554015

Coloplast A/S

15 October 2025

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