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Fit of made-to-measure compression garments in healthy subjects will be tested on one day, simulating daily activities.
Lower and upper extremities of 36 health subjects will be measured be trained experts to collect measures for made-to-measure compression garments.
Fit of made-to-measure compression garments, which are not on the market yet, among healthy subjects will be tested on one day, simulating daily activities. Fit will be assessed directly after donning and after a wearing period of maximum 7 hours at the study site by trained experts. Healthy subjects will give back study products at the end of the wearing period. AEs will be documented throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fit test of made-to-measure garments | Other | Healthy subjects will test maximum 2 compression garments out of 6 garments under investigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Made-to-measure compression garment | Device | Made-to-measure compression garment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the fit of the investigational device | Evaluation of the fit of the investigational medical device at the end of a wearing period of approximately 4 - 7 hours by predefined criteria, to be worn by healthy subjects once. | One day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Kröncke | Bioskin GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| bioskin GmbH | Hamburg | 20095 | Germany |
No IPD will be shared. Data are needed for confidential medical device development.
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Healthy subjects will test made-to-measure compression garments. No comparator group due to exploartive design
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