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Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

NCT05400421 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2022-06-06

No results posted yet for this study

Summary

Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.

Conditions

  • Aortic Pulse Wave Velocity

Interventions

DEVICE

System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure

Carotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds.

Sponsors & Collaborators

  • VitalSines International Inc.

    lead INDUSTRY

Principal Investigators

  • Jess Goodman, M.D. · VitalSines International Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

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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 NCT05400421 on ClinicalTrials.gov