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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age > 18
- •Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.
- •Patients receiving coronary artery bypass with or without valve repair.
- •Able to sign an informed consent.
排除标准
- •Refusal to sign an informed consent and to participate in the study.
- •Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.
- •Below the age of 18.
研究组 & 干预措施
Non Invasive Monitoring
Intervention: Device: Non invasive peripheral blood monitoring
干预措施: Non invasive peripheral blood monitoring (Device)
结局指标
主要结局
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.
时间窗: one year
To validate the parameters with similar measures obtained with standard invasive techniques in hospitalized patients. Methodology: Eligible real time color signal obtained by the TensorTip shall be recorded simultaneously during the monitoring performed. An algorithm shall be designed according to the blood color distribution to each parameter and a final test shall be recorded signals. Statistical analysis for each parameter shall perform on the entire eligible recorded signals. Determination of Accuracy: Err = √(1/N ∑N (Ref(k)-NewDevice(k)) \^2 ) (k=1) For each parameter a satisfactory result is considered when Err satisfies the industry requirement. Results viewing Each parameter comparative study shall be presented on a (X,Y) plan versus a regression line where X - represents the results measured by TensorTip and Y - the reference results.
次要结局
未报告次要终点