Trial Outcomes & Findings for Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product (NCT NCT05200416)

NCT ID: NCT05200416

Last Updated: 2025-01-23

Results Overview

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, which can be converted into a combined numerical score. The scale ranges from 0-100, where a score of 100 equals no impact and a score of 0 represents full impact.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Test Product - Heylo First, Then Standard of Care Participants first used Heylo for 8 weeks ± 3 days. Then there was a cross-over and the participants used Standard of Care for 8 weeks ± 3 days. 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 There was no 'Washout' period	Standard of Care First, Then Test Product - Heylo Participants first used Standard of Care for 8 weeks ± 3 days. Then there was a cross-over and the participants used Heylo for 8 weeks ± 3 days. 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 There was no 'Washout' period
First Intervention (8 Weeks ± 3 Days) STARTED	72	72
First Intervention (8 Weeks ± 3 Days) Received Allocated Intervention	71	72
First Intervention (8 Weeks ± 3 Days) COMPLETED	68	66
First Intervention (8 Weeks ± 3 Days) NOT COMPLETED	4	6
Second Intervention (8 Weeks ± 3 Days) STARTED	68	66
Second Intervention (8 Weeks ± 3 Days) COMPLETED	66	58
Second Intervention (8 Weeks ± 3 Days) NOT COMPLETED	2	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=139 Participants Due to the cross-over study design, all participants were randomized to receive all interventions. Baseline data has therefore been reported for all 'All Study Participants' being part of the Intention-to-Treat Population.
Age, Continuous	50.7 years STANDARD_DEVIATION 13.5 • n=139 Participants
Sex: Female, Male Female	71 Participants n=139 Participants
Sex: Female, Male Male	68 Participants n=139 Participants
Region of Enrollment Germany	139 participants n=139 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: The intention-to-treat (ITT) population (full analysis set) was constituted of all randomized subjects with valid informed consent who had been exposed to at least one product, and with information on at least one endpoint. Heylo --\> Standard of Care: Analyzed (n=68) / Excluded from analysis (n=4) (Reasons: Only baseline data (n=4)). Standard of Care --\> Heylo: Analyzed (n=71) / Excluded from analysis (n=1) (Reason: Only baseline data (n=1)).

Outcome measures

Outcome measures
Measure	Test Product - Heylo n=139 Participants The arm includes the test product Heylo Participants first used Heylo for 8 weeks ± 3 days. Then there was a cross-over and the participants used Standard of Care for 8 weeks ± 3 days. 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	Standard of Care n=139 Participants The arm includes Standard of Care Participants first used Standard of Care for 8 weeks ± 3 days. Then there was a cross-over and the participants used Heylo for 8 weeks ± 3 days. 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
Emotional Impact Score (Scale From 0-100)	73.4 score on a scale Interval 68.9 to 77.9	62.0 score on a scale Interval 57.6 to 66.4

SECONDARY outcome

Timeframe: 8 weeks

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, which can be converted into a combined domain score. Each domain has a range of 0-100, where low scores equal better health and high scores indicate greater disability.

Outcome measures

Outcome measures
Measure	Test Product - Heylo n=139 Participants The arm includes the test product Heylo Participants first used Heylo for 8 weeks ± 3 days. Then there was a cross-over and the participants used Standard of Care for 8 weeks ± 3 days. 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	Standard of Care n=139 Participants The arm includes Standard of Care Participants first used Standard of Care for 8 weeks ± 3 days. Then there was a cross-over and the participants used Heylo for 8 weeks ± 3 days. 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
Participation in Society Domain Score (Scale From 0-100)	33.0 score on a scale Interval 28.9 to 37.0	37.1 score on a scale Interval 33.1 to 41.2

Adverse Events

Test Product - Heylo

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Standard of Care

Serious events: 4 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Test Product - Heylo n=144 participants at risk The arm includes the test product Heylo Participants first used Heylo for 8 weeks ± 3 days. Then there was a cross-over and the participants used Standard of Care for 8 weeks ± 3 days. 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	Standard of Care n=144 participants at risk The arm includes Standard of Care Participants first used Standard of Care for 8 weeks ± 3 days. Then there was a cross-over and the participants used Heylo for 8 weeks ± 3 days. 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
Surgical and medical procedures Morbus Crohn boost / new stoma	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Surgical and medical procedures Peritonitis	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Hepatobiliary disorders Dysfunction of the gall bladder	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Infections and infestations Pneumonia	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Surgical and medical procedures Prolapse	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Surgical and medical procedures Thyroid Surgery	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Surgical and medical procedures Early stoma re-operation	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.
Surgical and medical procedures Morbus Crohn boost	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.69% 1/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.

Other adverse events

Other adverse events
Measure	Test Product - Heylo n=144 participants at risk The arm includes the test product Heylo Participants first used Heylo for 8 weeks ± 3 days. Then there was a cross-over and the participants used Standard of Care for 8 weeks ± 3 days. 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	Standard of Care n=144 participants at risk The arm includes Standard of Care Participants first used Standard of Care for 8 weeks ± 3 days. Then there was a cross-over and the participants used Heylo for 8 weeks ± 3 days. 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
Skin and subcutaneous tissue disorders Skin redness and irritation	3.5% 5/144 • Number of events 5 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.	0.00% 0/144 • Adverse events were recorded during the study period being 16 weeks ± 6 days. Mortality and Serious Adverse Events were assessed by investigators to not being related to the Test Product, nor Standard of Care.

Additional Information

Senior Clinical Strategy Project Manager

Coloplast A/S

Phone: +4549111341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place