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| Name | Class |
|---|---|
| MEDEDUS, Ljubljana, Slovenia | UNKNOWN |
| Adria Lab, Ljubljana, Slovenia | UNKNOWN |
| Vizera d.o.o. | INDUSTRY |
| Faculty of Pharmacy, Ljubljana, Slovenia |
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This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitastiq device | Experimental | Vitastiq device is used for about 2 months to perform Vitastiq readings every day, preferably in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitasitiq device | Device | Participant uses Vitastiq device for about 2 months to perform Vitastiq readings every day, preferably in the morning. On day 1, 29 and 57 participants' blood sampling is collected and analysed, and measurements using Vitastiq device are performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Vitastiq device accuracy and performance | Vitastiq accuracy performance is at least 70% meaning that at least 70% of Vitastiq readings for each mineral and vitamin fall within the range of matching blood test results. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Vitastiq readings method is repeatable | Vitastiq readings method is at least 80% repeatable. It means that at least 80% of Vitastiq readings for each mineral and vitamin performed by investigators and participant in the time frame of 30 minutes are comparable. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adria Lab d.o.o. | Ljubljana | 1000 | Slovenia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 26, 2018 | |
| Reset | Sep 21, 2018 | |
| Release | Apr 25, 2019 | |
| Reset | Jul 19, 2019 |
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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 | May 3, 2017 | Jan 5, 2018 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 26, 2018 | Sep 21, 2018 | |||
| Apr 25, 2019 |
| UNKNOWN |
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| Jul 19, 2019 |