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TerminatedNCT02766010Updated Jan 28, 2020

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

An interventional study of TensorTip in Blood Pressure, sponsored by Cnoga Medical Ltd.. Terminated. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-28.

Sponsored by Cnoga Medical Ltd. · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

  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
Read the detailed 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).
02

Conditions studied

  • Blood Pressure
03

In context

Lead sponsor

Cnoga Medical Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    group A TensorTip

    Male or female, age \> 18

    Device: TensorTip

Interventions

  • DeviceTensorTip

    Non Invasive screening of various physiological and hematological parameters.

    Also known as: Cnoga Medical Ltd. h SofTouch, SoftTouc

06

What researchers measure

Primary outcomes

  1. blood pressure measurement of the TensorTip against hospital readings

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02766010
Lead sponsor
Cnoga Medical Ltd.
Responsible party
Sponsor
First posted
May 9, 2016
Start date
May 22, 2016
Primary completion
Aug 29, 2016
Completion
Aug 29, 2016
Last update
Jan 28, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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