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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02766010
• Other study ID #: CM-CL-P-PHY-002
• Status: Terminated
• Phase: N/A
• Start date: May 22, 2016
• Est. completion date: August 29, 2016

Study information

• Verified date: April 2016
• Source: Cnoga Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: August 29, 2016
• Est. primary completion date: August 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• TensorTip
Non Invasive screening of various physiological and hematological parameters.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cnoga Medical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure measurement of the TensorTip against hospital readings		3 months