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

Not Applicable

Completed

• Conditions: Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters
• Interventions: Device: Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)

• Registration Number: NCT00712361
• Lead Sponsor: Cnoga Medical Ltd.

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-09
• Study First Posted: 2008-07-10
• Status Verified: 2009-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2020-01-26
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)	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.

Primary Outcome Measures

Name	Time	Method
Non Invasive Screening of: Glucose, Hemoglobin, Hematocrit, Blood Pressure, Pulse, SpO2, CO2, pH.	up to 2 minutes

Trial Locations

Locations (4)

Carmel Medical Center; 🇮🇱 Haifa, Israel

Patient's residence; 🇮🇱 Patient's Residence City, Patinet's Residence Province, Israel

Lin Medical Center; 🇮🇱 Haifa, Israel

CNOGA Medical Ltd.; 🇮🇱 Or 'Aqiva, Israel