NCT04017611

Desaturation Validation of INVSENSOR00038

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. One investigational sensor (INVSENSOR00038) will be placed on the somatic site of the volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-cleared sensor placed on the somatic site on the contralateral side. Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	INVSENSOR00038	Noninvasive regional oximeter

Timeline

• Start date: 2019-07-08
• Primary completion: 2019-07-19
• Completion: 2019-07-19
• First posted: 2019-07-12
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study