Trial Outcomes & Findings for A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters (NCT NCT01196533)

NCT ID: NCT01196533

Last Updated: 2019-01-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: one year
• Results posted on: 2019-01-31

Participant Flow

during 2009

Participant milestones

Measure	Non Invasive Monitoring Single group of hospitalized cardiovascular patients. Non invasive peripheral blood monitoring: non invasive monitoring
Overall Study STARTED	94
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters

Baseline characteristics by cohort

Measure	Non Invasive Monitoring n=94 Participants single group of hospitalized cardiovascular patients
Age, Continuous	51.5 years n=93 Participants
Sex/Gender, Customized number of participants	94 Participants n=93 Participants
Sex/Gender, Customized Male	45 Participants n=93 Participants
Sex/Gender, Customized Female	49 Participants n=93 Participants
Region of Enrollment United States	94 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Non Invasive Monitoring n=94 Participants single group of hospitalized cardiovascular patients
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. pulse	0.6 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Blood Pressure-systolic	7.9 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Blood Pressure-diastolic	7.5 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Spo2	2.33 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. PO2	5.99 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. PCO2	5.3 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. MAP	6.67 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Hemoglobin	8.9 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. cardiac output	26.9 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Hematocrit	3.8 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. RBC	4 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. O2	1.15 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. CO2	4.75 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. Stroke volume	26.9 percentage of error
Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. pH	0.03 percentage of error

Adverse Events

Non Invasive Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Frank Smart

Morristowm Memorial Hospital

Phone: 973-214-2601

Email: frank.smart@atlantichealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place