A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological Parameters and Blood Parameters
|ClinicalTrials.gov Identifier: NCT01196533|
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : February 10, 2015
The aim of the clinical trial is to study the accuracy of the TensorTip device compared with registered (FDA-approved) invasive and non-invasive devices.
Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip finger-mounted device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration.
|Condition or disease||Intervention/treatment||Phase|
|Accuracy of the TensorTip Device Compared With Standard Hospital Physiology and Lab Measurements.||Device: Non invasive peripheral blood monitoring||Not Applicable|
The TensorTip (previously named Soft Touch) is a novel non invasive Finger tip device that. The Tensor Tip is a non-invasive device which was designed and aimed to measure a wide range of physiological and bio-parameters such as blood glucose, hemoglobin and hematocrit, blood PH, oxygen saturation SpO2, blood carbon dioxide, blood pressure, peripheral pulse and more based on the temporarily color distribution of the tissue under consideration. The Tensor Tip is based on real time color image sensor, real time photographing the fingertip tissue. A color image sensor of the type used in the Tensor Tip enables a wide range of information in the spectral, resolution, dynamic range and time domains enabling further investigation of the blood chromatic changes as a function body physiology. The concept behind this investigation reflects the idea that a change in human physiology condition would temporarily change the blood pigmentation.
The present study is aimed to assess the accuracy of the novel device in measuring all the above mentioned parameters by recording AS IS the change of the fingertip color tissue while simultaneous recording the standard invasive measured parameters on daily or periodic routine in the hospitalized patients.
This vast data recordings (tissue and references) enable the Tensor tip to analyze a particular bio parameter. The tensor tip is calibrated to a certain bio parameter based on the vast data set collected.
The bio parameter under consideration are: Arterial Systolic and Diastolic, MAP, PA systolic, PA Diastolic, CO, Heart rate, Stroke volume, WBC, RBC, Hgb, HCT ,Iron, PLT, PH, PCO2, PO2, HCO3, SaO2 , Na, K, Cl, CO2, Bun, Cr, Gluc, HGB (A1C),TBiLi, LDL, HDL.
This study hopes to demonstrate the connection between blood color pigmentation and certain bio parameters for simplifying monitoring procedure and particular home monitoring.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Comparative Clinical Trial to Assess the Accuracy of the TensorTip, a Novel Non Invasive Device for the Measurement of Physiological and Blood Chemistry Parameters|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||August 2014|
Experimental: Non Invasive Monitoring
Single group of hospitalized cardiovascular patients.
Device: Non invasive peripheral blood monitoring
non invasive monitoring
- Comparison of the TensorTip accuracy against hospital periodical readings. [ Time Frame: app 2 minute for each recording. ]To validate the physiologic (BP, HR, Spo2, Perfusion, pCo2, pO2, SV and other physiology patrameters) and blood chemistry (Hgb,Hct, Glucose, and others blood chemistry parameters) with similar measures obtained simultanously with standard invasive techniques in hospitalized patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196533
|United States, New Jersey|
|Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine|
|Morristown, New Jersey, United States, 07962-1905|
|Principal Investigator:||Frank Smart, M.D||Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health|
|Study Chair:||Yosef Segman, PhD||Cnoga Medical Ltd.|
|Study Director:||Donna Hesari, BSN||Atlantic Health System, Department of Cardiovascular Medicine|