Clinical trial NCT05200416: Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
Official title: A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Colostomy Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 (assessed 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

Primary outcomes:
measure: Emotional Impact Score (Scale From 0-100)
timeFrame: 8 weeks
Secondary outcomes:
measure: Participation in Society Domain Score (Scale From 0-100)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergisch Gladbach
country: Germany
facility: Peter C. Ambe
state: Bergisch Gladbach,Nordrhein-Westfalen
Study officials:
affiliation: GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany
name: Peter C. Ambe, Dr.med
role: PRINCIPAL_INVESTIGATOR
References: