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

Modulated Imaging

Status: Unknown

Conditions: Circulatory; Change

Treatments: Device: The Ox-Imager Mini (Desaturation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03563105

900-0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Desaturation

Experimental group

Description:

Vascular Occlusion Test

Treatment:

Device: The Ox-Imager Mini (Desaturation)