A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device

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.

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.

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.

INCLUSION CRITERIA:

Questions regarding INCLUSION must all be answered YES for subject study entry

1. Subject is 18 to 85 years of age? [ ]Yes

2. Finger skin surface to be tested is free of injury or skin disease? [ ]Yes

3. Subject is ambulatory? [ ]Yes

4. Subject is willing and able to comply with the study requirements? [ ]Yes

5. Subject is willing and able to provide written informed consent to participate in the study? [ ]Yes

   EXCLUSION CRITERIA:

   Questions regarding EXCLUSION must all be answered NO for subject study entry

6. Subject is currently hospitalized ambulatory free? [ ] No

7. Subject is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding 2 years. For the purposes of the present study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40gr of ethanol. Subject is currently on methadone maintenance treatment programs are NOT eligible for this study? [ ] No

8. Subject has a medical condition that requires frequent or prolonged use of systemic corticosteroids (eg. Severe asthma, severe arthritis or autoimmune conditions; organ transplantation, adrenal insufficiency)?[ ] No

9. The skin area to be tested clean of any damage (e.g. spotless, uncontaminated, dirt free, and hygienic)? [ ] No

10. Subject has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study (e.g. concurrent active malignancy; frequent or uncontrolled seizure disorder; severe psychiatric disorder requiring psychotropic medication; active tuberculosis, pneumonia or other severe infection under current treatment; lives in a country other than the investigative site; or has other medical or social circumstances likely to interfere with the schedule or evaluations? [ ] No

11. A history of treated malignancy that is not in complete remission of chemotherapy and/or radiotherapy and with additional surgical intervention during the preceding 3 years? [ ] No

12. Subject is enrolled or plans to enroll from this study for any personal reason ? [ ] No