NCT06947447

WatchPAT SpO2 Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Itamar-Medical, Israel · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Validate the SpO2 accuracy of the WatchPAT compared to arterial blood CO-Oximetry

Detailed description

The goal of this comparative, single-center, non-randomized study is to validate the SpO2 accuracy performance of the WatchPAT SpO2 sensor over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry in 24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old. The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels, while an investigational device will be placed on the fingers of both hands.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	No intervention	Device

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-05-02
• Completion: 2025-05-02
• First posted: 2025-04-27
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study