A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device

Cnoga Medical

Status: Terminated

Conditions: Blood Pressure

Treatments: Device: TensorTip

Study type: Interventional

Funder types: Industry

Identifiers

NCT02766010

CM-CL-P-PHY-002

Details and patient eligibility

About

1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH, Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium, Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine, Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac index, stoke volume and blood gases compared with the simultaneous results from hospital references device (when available)
2. Hypothesis- Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration

Full description

1. This is a comparative clinical trial in which the measurements obtained by the TensorTip device will be compared with those obtained by the reference devices used by the hospital on daily or periodic monitoring (the devices will be identified by name and version at the final report).
2. Eligible real time color signal obtained by the TensorTip during the measurement shall be recorded simultaneously with the measurements obtained by the reference devices (as described in the above point).

Enrollment: 48 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age > 18
2. Agree to sign voluntary inform consent.

Exclusion criteria

1. Refusal to sign an informed consent and to participate in the study.
2. Below the age of 18.
3. Finger size not suitable for the measurement chamber.
4. Injured skin in the measurement site.
5. Long fingernails

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 1 patient group

group A TensorTip

Experimental group

Description:

Male or female, age \> 18

Treatment:

Device: TensorTip