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Clinical Trial Summary

1. Aim:

SoftTouch is a non-invasive device intending for use in the temporarily quantitative measurement of peripheral blood biomarkers. The aim of the clinical trial is to study the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive and non-invasive devices.

2. Hypothesis:

Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.


Clinical Trial Description

Description of the Method:

1. The method of measuring non-invasive peripheral physiological parameters such as Pulse, Blood Pressure, Blood pH, SpO2, CO2, Hemoglobin, Blood Glucose, Hematocrit and additional physiological parameters is based on the color distribution of a human tissue. SoftTouch is a finger-mounted device incorporated a dedicated light source and a color image sensor similar to a digital camera. The light transverses and is reflected from the tissue under consideration. Analyzing the tissue color distribution of the sampled real-time video in the frequency color space time domain may provide certain information about the biomarkers and vital-signs under consideration. The current study's goal is to find out if the results accuracy are satisfactory compared with regulatory cleared devices by the FDA and other notified bodies.

2. The Patient signals shall be recorded as is for algorithm improvement, future research of additional bio parameters and calibration.

3. the device is declared calibrated if executed successfully on the entire recorded data.

4. for non invasive blood glucose the device shall be provided to selected diabetic patients for the own use at home. ;


Study Design


Related Conditions & MeSH terms

  • Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters

NCT number NCT00712361
Study type Interventional
Source Cnoga Medical Ltd.
Contact
Status Completed
Phase N/A
Start date July 2008
Completion date August 2014