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People with intestinal stomas (especially an ileostomy) 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, which has an adhesive sensor layer that should be place underneath the baseplate normally used by the subject.
Single arm design. Open-labelled Study duration: 21 days + 3 days.
Test product is a Digital Leakage Notification System. It consist of a sensor layer (worn beneath the baseplate), a transmitter attached to the sensor layer, a charger for charging of transmitter and an app, to be installed on a smartphone, which notifies the user of the status of their baseplate such as everything looks okay or there is a possible leakage.
Subjects are asked to use test product for 21 days. n=15 were using a phone with Android operating system and n=10 a phone with iOS operating system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test product | Experimental | Subjects are requested to use the test device (supporting product) beneath their ostomy baseplate. Subjects may change their appliance as they wish, either they may change due to a notification from the app and/or follow their change routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP321 | Device | The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| System Performance Accuracy of Pictures | The primary endpoint is system performance accuracy:
| 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Leakage Onto Clothes Before and After Use of Test Product | Subjects are asked to recall numbers of leakage events outside baseplate (and/or onto clothes) the past 3 weeks (at baseline and follow-up). Subjects shall give a specific frequency. | At V1 (baseline) and V2 (follow-up, Day 21) |
| Experience of Leakage Onto Clothes Compared to Only Using Usual Product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Meisner, MD | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36952372 | Derived | Brady RR, Fellows J, Meisner S, Olsen JK, Vestergaard M, Ajslev TA. A pilot study of a digital ostomy leakage notification system: impact on worry and quality of life. Br J Nurs. 2023 Mar 23;32(6):S4-S12. doi: 10.12968/bjon.2023.32.6.S4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Arm, Intention to Treat | All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured. Single arm, open-label investigation with subjects assigned to use test product for 21±3 days. Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Arm, Intention to Treat | All subjects enrolled into the study (n=25) who have at least one measure on any of the outcomes measured. |
| 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 | System Performance Accuracy of Pictures | The primary endpoint is system performance accuracy:
| Posted | Count of Units | Pictures | 21 days | Pictures | Pictures |
|
21 days
During Visit 2, potential (S)AE's was captured by the Principal Investigator, or delegate.
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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 | Subjects are requested to use the test device (supporting product) beneath their ostomy baseplate. Subjects may change their appliance as they wish, either they may change due to a notification from the app and/or follow their change routine. CP321: The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin redness and irritation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Red and irritated skin in the area where the leg of the sensorplate has been placed. Possibly or probably related to the device. Intensity: Mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs 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 | Mar 29, 2021 | Aug 30, 2023 | Prot_SAP_001.pdf |
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Single arm, open label study. Subjects are allocated to use test product for 3 weeks. Subjects will complete questionnaires at baseline (V1) and again after 3 weeks use of test product (V2). Comparative tests included: Baseline vs. follow-up measures.
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Subject own interpretation, Q: to which degree have you experienced leakage onto your clothes with test product?" (5-point scale: very low degree/not at all, low degree, some degree, high degree, very high degree). |
| V2 (follow-up, Day 21) |
| Reliability of Notifications | Subjects are asked to rate, Q: To which degree did you find notifications from the app reliable and trustworthy (5-point scale; very low degree, low degree, some degree, high degree, very high degree) | V2 (follow-up, Day 21) |
| Ability to Move With Test Product | Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse | V2 (follow-up, Day 21) |
| Subjects Worry of Leakage Before and After Use of Test Product | Q: Think back on the last 3 weeks - to which degree have you worried about leakage? Very high degree - High degree - Some degree - Low degree - Very low degree/Not at all | At V1 (baseline) and V2 (follow-up, Day 21) |
| Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No | V2 (follow-up, Day 21) |
| Confidence in Daily Life Compared to Only Using Usual Product | Q: Compared to your usual product, to which degree did the test product give you confidence in daily life? Much higher degree- Higher degree- Same degree - Lower degree- Much lower degree | V2 (follow-up, Day 21) |
| Feeling of Control With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control | V2 (follow-up, Day 21) |
| Control of Leakage Progression With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did the test product give you a feeling of control of leakage progression? Yes, higher control of leakage progression No, lower control of leakage progression | V2 (follow-up, Day 21) |
| Feeling of Security With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did you feel more or less secure with test product? | V2 (follow-up, Day 21) |
| Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product | Q: Compared with your usual product, did the test product affect your confidence to engage in social activities such as seeing friends, and do physical activities? I felt more confident - I felt less confident | V2 (follow-up, Day 21) |
| Evaluation of Sleep With Test Product Compared to Only Using Usual Product | Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same | V2 (follow-up, Day 21) |
| Confidence at Night With Test Product Compared to Only Using Usual Product | Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower | V2 (follow-up, Day 21) |
| Evaluation of Users' Preference | Q: Which product solution do you prefer? Own product - Own product with test product | V2 (follow-up, Day 21) |
| Reason for Preference | Q: What is your reason for preference? (Please tick all that apply)
| V2 (follow-up, Day 21) |
| Evaluation of Users' Peace of Mind With Test Product | Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree | V2 (follow-up, Day 21) |
| To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product | Overall, do you think the test product can improve your feeling of control and confidence to avoid leakage onto clothes and therefore improve your quality of life? Yes - No | V2 (follow-up, Day 21) |
| Adhesive Residue to Skin | To which degree did you experience adhesive residue to the skin in the area around the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree | V2 (follow-up, Day 21) |
| Adhesive Residue to Transmitter | To which degree did you experience adhesive residue on the backside of the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree | V2 (follow-up, Day 21) |
| 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 | All 25 subjects were recruited in Denmark | Count of Participants | Participants |
|
| Type of stoma | Count of Participants | Participants |
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| Secondary | Frequency of Leakage Onto Clothes Before and After Use of Test Product | Subjects are asked to recall numbers of leakage events outside baseplate (and/or onto clothes) the past 3 weeks (at baseline and follow-up). Subjects shall give a specific frequency. | Posted | Least Squares Mean | 95% Confidence Interval | Leakage episodes onto clothes | At V1 (baseline) and V2 (follow-up, Day 21) |
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| Secondary | Experience of Leakage Onto Clothes Compared to Only Using Usual Product | Subject own interpretation, Q: to which degree have you experienced leakage onto your clothes with test product?" (5-point scale: very low degree/not at all, low degree, some degree, high degree, very high degree). | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Reliability of Notifications | Subjects are asked to rate, Q: To which degree did you find notifications from the app reliable and trustworthy (5-point scale; very low degree, low degree, some degree, high degree, very high degree) | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Ability to Move With Test Product | Q: Compared to your usual product, how was your freedom to move with test product? Much better - better - Same - Worse - Much worse | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Subjects Worry of Leakage Before and After Use of Test Product | Q: Think back on the last 3 weeks - to which degree have you worried about leakage? Very high degree - High degree - Some degree - Low degree - Very low degree/Not at all | Due to technical reasons, data from the questionnaire at V2 for two subjects could not be retrieved from the phones and therefore have been omitted from statistical analyses. Data from the two subjects provided at V1 were included, whenever possible. Therefore, the total number of subjects in the statistical analyses at V1 was n=25, while at V2 the number was n=23. | Posted | Count of Participants | Participants | At V1 (baseline) and V2 (follow-up, Day 21) |
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| Secondary | Confidence to Avoid Full Leakage With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did you feel confident that you could avoid leakage onto clothes? Yes -No | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Confidence in Daily Life Compared to Only Using Usual Product | Q: Compared to your usual product, to which degree did the test product give you confidence in daily life? Much higher degree- Higher degree- Same degree - Lower degree- Much lower degree | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Feeling of Control With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did test product give you a feeling of leakage control? Yes, higher leakage control No, lower leakage control | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Control of Leakage Progression With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did the test product give you a feeling of control of leakage progression? Yes, higher control of leakage progression No, lower control of leakage progression | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Feeling of Security With Test Product Compared to Only Using Usual Product | Q: Compared to your usual product, did you feel more or less secure with test product? | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Evaluation of Confidence to Increase Social Activities With Test Product Compared to Only Using Usual Product | Q: Compared with your usual product, did the test product affect your confidence to engage in social activities such as seeing friends, and do physical activities? I felt more confident - I felt less confident | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Evaluation of Sleep With Test Product Compared to Only Using Usual Product | Q: Compared with your usual product, did the test product affect your sleep? Yes, to the better Yes, to the worse No, the same | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Confidence at Night With Test Product Compared to Only Using Usual Product | Compared with your usual product, to which degree did the test product give you confidence at night? Much higher - Higher - Same - Lower - Much lower | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Evaluation of Users' Preference | Q: Which product solution do you prefer? Own product - Own product with test product | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Reason for Preference | Q: What is your reason for preference? (Please tick all that apply)
| The 13 subjects with a preference for test product were asked for the reason(s) for this preference and the the 10 subjects with a preference for own product were asked for the reason(s) for this preference. | Posted | Number | Participants | V2 (follow-up, Day 21) |
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| Secondary | Evaluation of Users' Peace of Mind With Test Product | Q: To which degree did the test product give you peace of mind? Very high degree- High degree- Low degree- Very low degree | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | To Evaluate Users' Assessment of QoL With Test Product Compared to Usual Product | Overall, do you think the test product can improve your feeling of control and confidence to avoid leakage onto clothes and therefore improve your quality of life? Yes - No | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Adhesive Residue to Skin | To which degree did you experience adhesive residue to the skin in the area around the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| Secondary | Adhesive Residue to Transmitter | To which degree did you experience adhesive residue on the backside of the transmitter? Very low degree/Not at all - Low degree - Some degree - High degree -Very high degree | Posted | Count of Participants | Participants | V2 (follow-up, Day 21) |
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| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
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| Title | Measurements |
|---|---|
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| Low degree |
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| Very low degree / Not at all |
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| Other |
| Low degree |
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| Very low degree / Not at all |
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| Better |
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| Much better |
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| Some degree |
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| Low degree |
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| Very low degree / Not at all |
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| V2 |
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| Higher degree |
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| Much higher degree |
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| Higher degree |
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| Much higher degree |
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| Preference for test product : Feeling of security |
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| Preference for test product : Feeling of confidence |
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| Preference for test product : Less fear of leakage onto clothes |
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| Preference for test product : Discreet to wear |
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| Preference for test product : Discreetness in leakage control |
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| Preference for test product : Better sleep |
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| Preference for test product : Less embarrassment |
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| Preference for test product : Other |
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| Preference for own product : Body fit |
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| Preference for own product : Ability to bend and stretch |
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| Preference for own product : Feeling of security |
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| Preference for own product : Feeling of confidence |
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| Preference for own product : Less fear of leakage onto clothes |
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| Preference for own product : Discreet to wear |
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| Preference for own product : Discreetness in leakage control |
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| Preference for own product : Better sleep |
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| Preference for own product : Less embarrassment |
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| Preference for own product : Other |
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| Very low degree |
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| High degree |
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| Very high degree |
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| High degree |
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| Very high degree |
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