A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device
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|ClinicalTrials.gov Identifier: NCT00712361|
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : December 5, 2014
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters.||Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)||Not Applicable|
Description of the Method:
- 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.
- The Patient signals shall be recorded as is for algorithm improvement, future research of additional bio parameters and calibration.
- the device is declared calibrated if executed successfully on the entire recorded data.
- for non invasive blood glucose the device shall be provided to selected diabetic patients for the own use at home.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Comparative Clinical Trial to Assess the Accuracy of the SoftTouch. A Novel Non-invasive Device for Measuring Peripheral Blood Glucose, Carbon Dioxide, pH, Hemoglobin, Hematocrit, SpO2, Peripheral Pulse and Blood Pressure.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Group A
The group A incorporates three subgroups of individuals at various ages. A.1 Age: 16 - 30 A.2 Age: 31 - 60 A.3 Age > 60 All subgroups will be randomly distributed according to the following factors: BMI, gender, race and hematocrit.
Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)
Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.
- Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH. [ Time Frame: up to 2 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712361
|Patient's residence city, Patinet's residence Province, Israel|
|Carmel Medical Center|
|Lin Medical Center|
|CNOGA Medical Ltd.|
|Or Akiva, Israel, 30600|
|Principal Investigator:||Eli Zuckerman, Prof.||Carmel Medical Center - Head of Liver Unit|
|Study Chair:||Yosef Segman, PhD||Cnoga Medical Ltd.|