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The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEGâ„¢ medical A/S.
The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.
This study is Part II of the protocol. Part I is registered: NCT05111847
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-term Baseplate A and long-term Baseplate C, concomitant use | Other | All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseplate type A | Device | Type A: Acrylate tested for 35 days behind one ear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans epidermal water loss (TEWL) to measure skin-friendliness | To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear. High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis. | 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, Dr. | Bispebjerg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital | København NV | 2400 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 19, 2025 | |
| Reset | Jan 12, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2022 | Apr 10, 2025 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 19, 2025 | Jan 12, 2026 |
Following a cross-over design in Part I of the study, two of the four initial Baseplates, is tested for longer wear time (35 days) in this Part II of the study.
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| Baseplate type C | Device | Type C: Hydrocolloid tested for 35 days behind the other ear |
|