Trials / Terminated
TerminatedNCT02766010
A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device
A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device for the Measurement of Physiological and Hematological Parameters
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Cnoga Medical Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH, Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium, Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine, Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac index, stoke volume and blood gases compared with the simultaneous results from hospital references device (when available) 2. Hypothesis- Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration
Detailed description
1. This is a comparative clinical trial in which the measurements obtained by the TensorTip device will be compared with those obtained by the reference devices used by the hospital on daily or periodic monitoring (the devices will be identified by name and version at the final report). 2. Eligible real time color signal obtained by the TensorTip during the measurement shall be recorded simultaneously with the measurements obtained by the reference devices (as described in the above point).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TensorTip | Non Invasive screening of various physiological and hematological parameters. |
Timeline
- Start date
- 2016-05-22
- Primary completion
- 2016-08-29
- Completion
- 2016-08-29
- First posted
- 2016-05-09
- Last updated
- 2020-01-28
Source: ClinicalTrials.gov record NCT02766010. Inclusion in this directory is not an endorsement.