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

Not Applicable

Terminated

• Conditions: Blood Pressure
• Interventions: Device: TensorTip

• Registration Number: NCT02766010
• Lead Sponsor: Cnoga Medical Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-03-28
• Status Verified: 2016-04
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Study Start: 2016-05-22
• Primary Completion: 2016-08-29
• Study Completion: 2016-08-29
• Last Update Submitted: 2020-01-26
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group A TensorTip	TensorTip	Male or female, age \> 18

Primary Outcome Measures

Name	Time	Method
blood pressure measurement of the TensorTip against hospital readings	3 months