A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device

A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device for the Measurement of Physiological and Hematological Parameters

1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH, Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium, Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine, Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac index, stoke volume and blood gases compared with the simultaneous results from hospital references device (when available)
2. Hypothesis- Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip 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: Terminated
• Conditions: Blood Pressure
• Intervention / Treatment: Device: TensorTip

Detailed Description

1. This is a comparative clinical trial in which the measurements obtained by the TensorTip device will be compared with those obtained by the reference devices used by the hospital on daily or periodic monitoring (the devices will be identified by name and version at the final report).
2. Eligible real time color signal obtained by the TensorTip during the measurement shall be recorded simultaneously with the measurements obtained by the reference devices (as described in the above point).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, age > 18
2. Agree to sign voluntary inform consent.

Exclusion Criteria:

1. Refusal to sign an informed consent and to participate in the study.
2. Below the age of 18.
3. Finger size not suitable for the measurement chamber.
4. Injured skin in the measurement site.
5. Long fingernails

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A TensorTip; Male or female, age > 18	Device: TensorTip; Non Invasive screening of various physiological and hematological parameters.; Other Names: Cnoga Medical Ltd. h SofTouch; SoftTouc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood pressure measurement of the TensorTip against hospital readings	3 months

Collaborators and Investigators

• Sponsor: Cnoga Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2016
• Primary Completion (Actual): August 29, 2016
• Study Completion (Actual): August 29, 2016

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CM-CL-P-PHY-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No