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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center
  • Haifa, Israel
    • Lin Medical Center
  • Or 'Aqiva, Israel, 30600
    • Cnoga Medical Ltd.
  • Patinet's Residence Province
    • Patient's Residence City, Patinet's Residence Province, Israel
      • Patient's residence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; Other Names: Cnoga Medical Ltd.; SoftTouch; SofTouch; Soft-Touch; OnlyTouch; CM-CL-R-007; CMC 07015922; HT 4502; HTA 4502

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cnoga Medical Ltd.
• Collaborators: Carmel Medical Center
• Investigators: Principal Investigator: Eli Zuckerman, Prof., Carmel Medical Center - Head of Liver Unit

Publications and helpful links

General Publications

• References: 1. Indian J Med Res. 2007 Mar;125(3):275-96 2. Self-monitoring of blood glucose in diabetes. Drug Ther Bull. 2007 ;45(9):65-9. Blood glucose monitoring: reducing the cost, increasing the benefit. 4. Hussain F, Evans ND, Sachedina N, Pickup JC, In vivo glucose monitoring: the clinical reality and the promise. Biosens Bioelectron. 2005 Apr 15;20(10):1897-902. 5. Sims AJ, Menes JA, Bousfield DR, Reay CA, Murray A. Automated non-invasive blood pressure devices: are they suitable for use? Blood Press Monit. 2005 Oct;10(5):275-81. 6. Funahashi J, Ohkubo T, Fukunaga H, Kikuya M, Takada N, Asayama K, Metoki H, Obara T, Inoue R, Hashimoto J, Totsune K, Kobayashi M, Imai Y. The economic impact of the introduction of home blood pressure measurement for the diagnosis and treatment of hypertension. Blood Press Monit. 2005 Dec;10(6):307-10. 7. Bobrie G, Chatellier G, Genes N, Clerson P, Vaur L, Vaisse B, Menard J, Mallion JM. Cardiovascular prognosis of

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (ESTIMATE): July 10, 2008

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Accuracy; Blood pressure; Hemoglobin; Non-Invasive; pH; SpO2; Pulse; CO2; Hematocrit; Invasive; Peripheral blood parameters; Finger mounted device; Blood tissue; Tissue color distribution; Tissue pigmentation
• Other Study ID Numbers: CM-CL-R-007; CMC 07015922 CMC 07015409 (OTHER: Carmel); HT 4502 (OTHER: helsinki Carmel); HTA 4502 (OTHER: Carmel)