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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product - Heylo | Experimental | The arm includes the test product Heylo |
|
| Standard of Care | Active Comparator | The arm includes Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heylo | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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, 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C. Ambe, Dr.med | GFO Kliniken Rhein Berg, Vinzenz Pallotti Hospital, 51429 Bergisch Gladbach-Bensberg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter C. Ambe | Bergisch Gladbach | Bergisch Gladbach,Nordrhein-Westfalen | 51429 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40206623 | Derived | Ambe PC, Brunckhorst E, Hansen HD, Gotfredsen JL, Vestergaard M, Ajslev TA. Effect of a Novel Digital Leakage Notification System (Heylo) for Ostomy Care on Quality of Life and Burden of Living With an Intestinal Ostomy: The ASSISTER Trial, A Randomized Controlled Cross-Over Trial. Mayo Clin Proc Digit Health. 2023 Sep 1;1(3):438-449. doi: 10.1016/j.mcpdig.2023.06.013. eCollection 2023 Sep. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (8 Weeks ± 3 Days) |
| ||||||||||||||||
| Second Intervention (8 Weeks ± 3 Days) |
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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' (Intention-to-Treat Population).
Intention-to-Treat Population included randomized participants who had been exposed to at least 1 product and with information on at least 1 endpoint (n=139).
n=5 randomized participants only reported baseline data, and were not included in the ITT-Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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, 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. | 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)). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product - Heylo | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Morbus Crohn boost / new stoma | Surgical and medical procedures | Systematic Assessment | Product used: Standard of Care, Product: Not related, Procedure: Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin redness and irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed by Investigator as having a causal relationship, or were probably or possibly related to Test Product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Strategy Project Manager | Coloplast A/S | +4549111341 | dkteaa@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2021 | Apr 2, 2024 | Prot_SAP_000.pdf |
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| Standard of Care | Device | Standard of Care is the ostomy products (baseplate and bag) that the subject normally uses |
|
| 8 weeks |
| NOT COMPLETED |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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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 |
| OG001 | Standard of Care | 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 |
|
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| 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, 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. | 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)). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 8 weeks |
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| 1 |
| 144 |
| 3 |
| 144 |
| 5 |
| 144 |
| EG001 | Standard of Care | 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 | 2 | 144 | 4 | 144 | 0 | 144 |
|
| Peritonitis | Surgical and medical procedures | Systematic Assessment | Product used: Standard of Care, Product: Not related, Procedure: Not related |
|
| Dysfunction of the gall bladder | Hepatobiliary disorders | Systematic Assessment | Product used: Heylo, Product: Not related, Procedure: Not related |
|
| Pneumonia | Infections and infestations | Systematic Assessment | Product used: Heylo, Product: Not related, Procedure: Not related |
|
| Prolapse | Surgical and medical procedures | Systematic Assessment | Product used: Standard of Care, Product: Not related, Procedure: Not related |
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| Thyroid Surgery | Surgical and medical procedures | Systematic Assessment | Product used: Heylo, Product: Not related, Procedure: Not related |
|
| Early stoma re-operation | Surgical and medical procedures | Systematic Assessment | Product used: Heylo, Product: Not related, Procedure: Not related |
|
| Morbus Crohn boost | Surgical and medical procedures | Systematic Assessment | Product used: Standard of Care, Product: Not related, Procedure: Not related |
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