Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product

Ileostomy - Stoma Clinical Trial

Official title:

A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05200416
• Other study ID #: CP345
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: November 4, 2022

Study information

• Verified date: January 2023
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status. The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.

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 subjects having an ileostomy or an colostomy will be included and randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 (as-sessed by investigator or delegate)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma

Intervention

Device:
• Heylo
Heylo is used in combination with the ostomy baseplate usually used by the subjects. It will detect and notify the subject of the occurrence of output leakage under an ostomy baseplate.
• Standard of Care
Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses

Locations

Country	Name	City	State
Germany	Peter C. Ambe	Bergisch Gladbach	Bergisch Gladbach,Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional impact score (scale from 0-100)	Measured by the validated OLI scale evaluated at the end of each test period. The questionnaire regarding Emotional impact contains 10 questions where the 4 answer options are: All of the time, Often, Sometimes and Rarely or never.	8 weeks
Secondary	Participation in society domain score (scale from 0-100)	Measured by WHODAS 2.0 evaluated at the end of each test period. The questionnaire regarding Participation in society contains 11 questions where the 5 answer options are: None, Mild, Moderate, Severe and Extreme or cannot do.	8 weeks