Diabetes Clinical Trial
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
NCT number | NCT01196533 |
Other study ID # | CMIL-MHUS-V1.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2010 |
Est. completion date | August 2014 |
Verified date | July 2018 |
Source | Cnoga Medical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | August 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Atlantic Health - Morristown Memorial Hospital- Cardiovascular Medicine | Morristown | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Cnoga Medical Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. | 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 = v(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. |
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