N/A N=94 Screening

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

Anemia · Diabetes · Heart Disease · High Blood Pressure · Hypotension

Bottom Line

View on ClinicalTrials.gov: NCT01196533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcome: Primary: Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. — 0.6; 7.9; 7.5; 2.33 percentage of error

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Non invasive peripheral blood monitoring (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cnoga Medical Ltd.
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparison of the TensorTip Accuracy Against Hospital Periodical Readings.	0.6; 7.9; 7.5; 2.33; 5.99; 5.3	—

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.

Eligibility Criteria

Inclusion Criteria

Male or female, age > 18
Patients with cardiovascular disease and/or with diabetes mellitus type I or II and/or with COPD.
Patients receiving coronary artery bypass with or without valve repair.
Able to sign an informed consent.

Exclusion Criteria

Refusal to sign an informed consent and to participate in the study.
Participant plans to enroll in another other clinical trial of an investigational agent while participating in this study.
Below the age of 18.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01196533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.