Status:
COMPLETED
A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device
Lead Sponsor:
Cnoga Medical Ltd.
Collaborating Sponsors:
Carmel Medical Center
Conditions:
Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters
Eligibility:
All Genders
18-85 years
Phase:
NA
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 t...
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 ad...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Questions regarding INCLUSION must all be answered YES for subject study entry
- Subject is 18 to 85 years of age? \[ \]Yes
- Finger skin surface to be tested is free of injury or skin disease? \[ \]Yes
- Subject is ambulatory? \[ \]Yes
- Subject is willing and able to comply with the study requirements? \[ \]Yes
- 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
- Subject is currently hospitalized ambulatory free? \[ \] No
- 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
- 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
- The skin area to be tested clean of any damage (e.g. spotless, uncontaminated, dirt free, and hygienic)? \[ \] No
- 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
- 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
- Subject is enrolled or plans to enroll from this study for any personal reason ? \[ \] No
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00712361
Start Date
July 1 2008
End Date
August 1 2014
Last Update
January 28 2020
Active Locations (4)
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1
Patient's residence
Patient's Residence City, Patinet's Residence Province, Israel
2
Carmel Medical Center
Haifa, Israel
3
Lin Medical Center
Haifa, Israel
4
CNOGA Medical Ltd.
Or Akiva, Israel, 30600