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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 Heyloâ„¢, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product - new supporting ostomy product and support service | Other | The arm includes the newly developed supporting ostomy product (leakage notification system Heylo) used together with a support service |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heylo | Device | Test of the supporting product (test product) for a 12 weeks period. No additional intervention will be conducted. A few follow up nurse calls to assess few endpoints together with subject. All remaining endpoints are captured via surveys send to the subjects every 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks | Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)? | Baseline (Day 0) and Final Evaluation (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Self-management | Patient Activation Measure (PAM) score The Patient Activation Measurement (PAM) is scored on a scale ranging from 0 to 100. Individuals who score high on this instrument typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so. | Baseline (Day 0) and Final Evaluation (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Brady | Newcastle-upon-Tyne Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead/North Bristol NHS Trust | Bristol | United Kingdom | ||||
| Chelsea & Westminster Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39792106 | Derived | Brady RR, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial. Br J Nurs. 2025 Jan 13;34(1):14-22. doi: 10.12968/bjon.2025.0278. | |
| 39407731 | Derived | Brady RRW, Sheard D, Alty M, Vestergaard M, Boisen EB, Ainsworth R, Hansen HD, Ajslev TA. Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial. J Clin Med. 2024 Sep 24;13(19):5673. doi: 10.3390/jcm13195673. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product - New Supporting Ostomy Product and Support Service | The arm includes the newly developed ostomy support product together with a support service Heylo: Test of the supporting product (test product) for a 12 weeks period. No measurement will be conducted. All endpoints are captured via surveys send to the subjects every 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 21, 2022 |
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| Ostomy Leakage Impact Tool - 'Emotional Impact' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Baseline (Day 0) and Final Evaluation (Week 12) |
| Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Baseline (Day 0) and Final Evaluation (Week 12) |
| Ostomy Leakage Impact Tool - 'Coping and in Control' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Baseline (Day 0) and Final Evaluation (Week 12) |
| Health Related Quality of Life | The EQ-5D-5L instrument consists of five dimensions with five predetermined levels of response that is used to generate a health state profile, which then can be assigned a summary index score. Translation of health states and index scores are based on the specific value set for United Kingdom. The index scores based on the value set for United Kingdom ranges from -0.285 to 1. Index score of -0.285 is the worst health state. Index score of 1 is the best health state. | Baseline (Day 0) and Final Evaluation (Week 12) |
| EQ-5D-5L Visual Analogue Scale (VAS) | Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health). | Baseline (Day 0) and Final Evaluation (Week 12) |
| Chelsea |
| United Kingdom |
| Devon/Royal Devon and Exeter NHS Foundation Trust | Exeter | United Kingdom |
| Norfolk/James Paget University Hospitals NHS Foundation Trust | Great Yarmouth | United Kingdom |
| Leeds/Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| Illingworth | Manchester | United Kingdom |
| Middlesbrough/South Tees NHS trust, James Cook University Hospital | Middlesbrough | United Kingdom |
| Newcastle University/The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | NE3 3HD | United Kingdom |
| Petersborough/ North West Anglia NHS Foundation trust, Petersborough City Hospital | Peterborough | United Kingdom |
| Preston/Lancashire Teaching Hospitals NHS Trust, Royal Preston Hospital | Preston | United Kingdom |
| Baseline (Intention to Treat Population) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product - New Supporting Ostomy Product and Support Service | The arm includes the newly developed ostomy support product together with a support service Heylo: Test of the supporting product (test product) for a 12 weeks period. No measurement will be conducted. All endpoints are captured via surveys send to the subjects every 14 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Times With Stoma Effluent Leakage Outside the Baseplate (e.g. Onto Clothes or Bedsheets) Within the Last 2 Weeks | Survey question: Think back on the last 2 weeks; how many times have you experienced stoma effluent leakage outside the baseplate (e.g. onto clothes or bedsheets)? | Posted | Least Squares Mean | 95% Confidence Interval | Number of leakages per two weeks | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | Patient Self-management | Patient Activation Measure (PAM) score The Patient Activation Measurement (PAM) is scored on a scale ranging from 0 to 100. Individuals who score high on this instrument typically understand the importance of taking a pro-active role in managing their health and have the skills and confidence to do so. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | Ostomy Leakage Impact Tool - 'Emotional Impact' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | Ostomy Leakage Impact Tool - 'Usual and Social Activities' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | Ostomy Leakage Impact Tool - 'Coping and in Control' Domain | Leakage-related quality of life. The Ostomy Leakage Impact (OLI) tool consists of 22 item questions, which are grouped in three domains. The three domains concern the impact of stoma leakage on (1) 'emotional' aspects, (2) 'usual and social activities', and (3) 'coping and in control'. Each domain has a score ranging from 0-100. A score of 100 equals no impact and a score of 0 represents full negative impact, thus a higher score means that subjects are less impacted from leakage in their daily life. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | Health Related Quality of Life | The EQ-5D-5L instrument consists of five dimensions with five predetermined levels of response that is used to generate a health state profile, which then can be assigned a summary index score. Translation of health states and index scores are based on the specific value set for United Kingdom. The index scores based on the value set for United Kingdom ranges from -0.285 to 1. Index score of -0.285 is the worst health state. Index score of 1 is the best health state. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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| Secondary | EQ-5D-5L Visual Analogue Scale (VAS) | Subjects rate their perceived health from 0 (worst imaginable health) to 100 (best imaginable health). | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Day 0) and Final Evaluation (Week 12) |
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Adverse events were recorded during the study period being 12 weeks ± 2 weeks.
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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 | Safety Population | n=100 subjects were recruited for the study. All n=100 subjects were included as the safety population. Eight subjects were omitted from the ITT population, as they had not used the Test Product. Six of the eight subjects were screening failures, a single subject wished to discontinue, and a single subject was lost to follow-up before the first visit (V1; baseline). | 0 | 100 | 5 | 100 | 20 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Patient was admitted into the hospital for subarachnoid hemorrhage and encephalitis | Nervous system disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Low Neutrophils | Blood and lymphatic system disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Bleeding Stoma | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Admitted to hospital as a result for producing high output black stoma contents | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Intestinal Blockage | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Intestinal infection | Gastrointestinal disorders | Systematic Assessment | Not related to Test Product (Assessed by investigators) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin redness and irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed by investigators to be possibly, probably, or causally related to the Test Product |
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| Headache | Nervous system disorders | Systematic Assessment | Not related to Test Product; Not related to Procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Strategy Project Manager | Coloplast A/S | +4549111341 | dkteaa@coloplast.com |
| Apr 2, 2024 |
| Prot_SAP_000.pdf |
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