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

NCT01196533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-01-31

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Non invasive peripheral blood monitoring

non invasive monitoring

Sponsors & Collaborators

  • Cnoga Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Frank Smart, M.D · Chairman of the Cardiovascular Medicine Department at Morritwon Memorial Hospital and Atlantic Health

  • Yosef Segman, PhD · Cnoga Medical Ltd.

  • Donna Hesari, BSN · Atlantic Health System, Department of Cardiovascular Medicine

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-07-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01196533 on ClinicalTrials.gov