N/A
Completed N=94
A Comparative Clinical Trial of the TensorTip, a Novel Non Invasive Device for Measurement Blood Parameters
Source: ClinicalTrials.gov NCT01196533 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Comparison of the TensorTip Accuracy Against Hospital Periodical Readings. — 0.6; 7.9; 7.5; 2.33 percentage of error
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.
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 | — |
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.
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. Informational only — not medical advice.