A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device
NCT00712361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2020-01-28
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.
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)
Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.
Sponsors & Collaborators
-
Carmel Medical Center
collaborator OTHER -
Cnoga Medical Ltd.
lead INDUSTRY
Principal Investigators
-
Eli Zuckerman, Prof. · Carmel Medical Center - Head of Liver Unit
-
Yosef Segman, PhD · Cnoga Medical Ltd.
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-08-31
Countries
- Israel
Study Locations
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