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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766010

Enrollment

Registered

2016-05-09

Start date

2016-05-22

Completion date

2016-08-29

Last updated

2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

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).

Interventions

DEVICETensorTip

Non Invasive screening of various physiological and hematological parameters.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026