NCT02766010

Brief Summary

  1. 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. 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

May 22, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2016

Completed
Last Updated

January 28, 2020

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

March 28, 2016

Last Update Submit

January 26, 2020

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • blood pressure measurement of the TensorTip against hospital readings

    3 months

Study Arms (1)

group A TensorTip

EXPERIMENTAL

Male or female, age \> 18

Device: TensorTip

Interventions

TensorTipDEVICE

Non Invasive screening of various physiological and hematological parameters.

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, age \> 18
  • Agree to sign voluntary inform consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2016

First Posted

May 9, 2016

Study Start

May 22, 2016

Primary Completion

August 29, 2016

Study Completion

August 29, 2016

Last Updated

January 28, 2020

Record last verified: 2016-04