Status:
COMPLETED
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
Lead Sponsor:
Coloplast A/S
Conditions:
Ileostomy - Stoma
Colostomy Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively. To overcome this, Coloplast has develope...
Detailed Description
The Investigational device - Heylo, is already CE-marked. The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care. In total 144...
Eligibility Criteria
Inclusion
- Has given written consent to participate by signing the Informed Consent Signature Form.
- Is at least 18 years of age and has full legal capacity.
- Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale\*)
- Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
- Has experienced leakage\*\* under the baseplate at least three times within the last fourteen days. \*\*Leakage defined as output seeping under the baseplate"
- Has worry about leakage to "some degree, high degree, or very high degree" (on a five-point Likert scale: Very low degree/Not at all, Low degree, some degree, High degree, very high degree)
- Is willing to refrain from use of ostomy paste.
- Has a smartphone compatible with the Heylo™ application
- Is able to follow study procedures for 4 months (assessed by investigator or delegate)
Exclusion
- Is participating in other clinical investigations or has previously participated in this investigation
- Is pregnant or breastfeeding
- Has known hypersensitivity towards any of the products used in the investigation
- Is using/ has a pacemaker
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05200416
Start Date
January 13 2022
End Date
November 4 2022
Last Update
January 23 2025
Active Locations (1)
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1
Peter C. Ambe
Bergisch Gladbach, Bergisch Gladbach,Nordrhein-Westfalen, Germany, 51429