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The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test patch | Experimental | two adhesive patches are applied to the abdominal area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test patch | Other | the test patch consists of an adhesive patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resistance (Moisture in the Adhesive) | The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene F Nielsen | Head of the pre-clinical department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities | Two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Patch | two adhesive patches are applied to the abdominal area test patch: the test patch consists of an adhesive patch |
| 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 | Resistance (Moisture in the Adhesive) | The outcome measure is described as number of events where the sensor system reacted to a false positive leak. Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks. | Healthy volunteers | Posted | Number | Number of false positive leaks | 3 days |
|
3 days
[Not specified]
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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 Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities | Two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Schnipper, Medical Writer | Coloplast A/S | 49111257 | dkjuls@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 23, 2023 | Jun 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010328 | Patch Tests |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
|
| OG001 | Test Patch (Adhesive Patch With Sensor System) + Hard Physical Activities + Normal Daily Activities | two adhesive patches are applied to the abdominal area on two consecutive days. The first patch is worn with normal daily activities and the second patch is stress tested during half an hour spinning activities in humid environment plus normal day activities. |
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| 0 |
| 6 |
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| 6 |
| 0 |
| 6 |
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| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |