A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology, Cardiology, Anemia, Endocrine, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Hematology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/2/2019 |
| Start Date: | August 2010 |
| End Date: | August 2014 |
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
1. Aim:
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.
2. Hypothesis:
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.
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.
2. Hypothesis:
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.
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.
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.
Inclusion Criteria:
1. Male or female, age > 18
2. Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or
with COPD.
3. Patients receiving coronary artery bypass with or without valve repair.
4. Able to sign an informed consent.
Exclusion Criteria:
1. Refusal to sign an informed consent and to participate in the study.
2. Participant plans to enroll in another other clinical trial of an investigational
agent while participating in this study.
3. Below the age of 18.
We found this trial at
1
site
Morristown, New Jersey 07962
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