Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
NCT06634693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12
Last updated 2024-10-10
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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