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

Circulatory; Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03563105
• Other study ID #: 900-0003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2018
• Source: Modulated Imaging Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulatory; Change

Intervention

Device:
• The Ox-Imager Mini (Desaturation)
Vascular Occlusion Test

Locations

Country	Name	City	State
United States	Orange County Wound and Hyperbaric	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
Modulated Imaging Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant decrease in StO2 during occlusion	significant decrease in StO2 during occlusion	immediate