NCT03563105

Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Modulated Imaging Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.

Detailed description

The objective of this study is to demonstrate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system, "The Ox-Imager Mini". Potential circulatory compromise will be imaged in healthy volunteers using both the subject and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model is an established paradigm to introduce transient ischemia in skin and the the subjects will be imaged during this time. The primary endpoint will be to measure significant decrease in tissue oxygen saturation after occlusion for both predicate and subject devices.

Conditions

• Circulatory; Change

Interventions

Type	Name	Description
DEVICE	The Ox-Imager Mini (Desaturation)	Vascular Occlusion Test

Timeline

• Start date: 2018-05-30
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2018-06-20
• Last updated: 2018-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study