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

Coloplast A/S100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Stoma Ileostomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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\]

Locations (1)

Coloplast A/S

Humlebæk, Denmark

RECRUITING

Outcomes

Primary Outcomes

Primary endpoint

Stoma-related QoL measured by the Emotional Leakage Impact score (domain 1 of OLI) at baseline (0 months), 6, 9 and 12 months

Time frame: one year

Central Contacts

Thomas Krarup Simonsen

CONTACT

+4549111873 dktksi@coloplast.com

Data from ClinicalTrials.gov

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