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

Modulated Imaging Inc.50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Circulatory; Change

Interventions

The Ox-Imager Mini (Desaturation)DEVICE

Vascular Occlusion Test

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Over 18 years of age Exclusion Criteria: * History of congestive heart failure * Patients with existing wound or ulcer. * Rheumatoid arthritis * Pregnant or lactating women

Locations (1)

Orange County Wound and Hyperbaric

Santa Ana, California, United States

Outcomes

Primary Outcomes

Significant decrease in StO2 during occlusion

significant decrease in StO2 during occlusion

Time frame: immediate

Data from ClinicalTrials.gov

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