Controlled Desaturation Study for TipTraQ SpO2 Performance Validation

NCT06634693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2024-10-10

No results posted yet for this study

Summary

The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019.

Conditions

Sponsors & Collaborators

  • PranaQ Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip Bickler, MD, PhD · University of California, San Francisco

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2023-10-11
Completion
2023-10-11

Countries

  • United States

Study Locations

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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 NCT06634693 on ClinicalTrials.gov