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

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05200416
• Collaborator: (none)
• Enrollment: 144
• Arms: 2
• Anticipated Duration (Months): 10

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Ileostomy - Stoma; Colostomy Stoma	Device: Heylo; Device: Standard of Care	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Product - Heylo The Test product will be used together with the subjects own ostomy products. Subjects will change the products as usual, according to their normal change routine	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.; Device: Standard of Care; Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses
Active Comparator: Standard of Care In the Standard of Care arm, the subjects will only use their own ostomy products. Subjects will change the products as usual, according to their normal change routine	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.; Device: Standard of Care; Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses

Outcome Measures

Primary Outcome Measures

1. Emotional impact score [16 weeks +/- 6 days]

   Measured by the validated OLI scale evaluated at the end of each test period

Secondary Outcome Measures

1. Participation in society domain score [16 week +/- 6 days]

   Measured by WHODAS evaluated at the end of each test period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Has given written consent to participate by signing the Informed Consent Signature Form.

2. Is at least 18 years of age and has full legal capacity.

3. Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale*)

4. Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).

5. Has experienced leakage** under the baseplate at least three times within the last fourteen days. **Leakage defined as output seeping under the baseplate"

6. 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)

7. Is willing to refrain from use of ostomy paste.

8. Has a smartphone compatible with the Heylo™ application

9. Is able to follow study procedures for 4 months (as-sessed by investigator or delegate)

Exclusion Criteria:

1. Is participating in other clinical investigations or has previously participated in this investigation 2. Is pregnant or breastfeeding 3. Has known hypersensitivity towards any of the products used in the investigation 4. Is using/ has a pacemaker

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Coloplast A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT05200416
• Other Study ID Numbers: CP345
• First Posted: Jan 20, 2022
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 20, 2022