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

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ClinicalTrials.gov Identifier: NCT03563105
Recruitment Status : Unknown
Verified June 2018 by Modulated Imaging Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Modulated Imaging Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Circulatory; Change Device: The Ox-Imager Mini (Desaturation) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Vascular Occlusion Test
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Desaturation
Vascular Occlusion Test
 Device: The Ox-Imager Mini (Desaturation)
Vascular Occlusion Test


Outcome Measures
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Primary Outcome Measures :
  1. Significant decrease in StO2 during occlusion [ Time Frame: immediate ]
    significant decrease in StO2 during occlusion


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563105


Locations
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United States, California
Orange County Wound and Hyperbaric
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Modulated Imaging Inc.
Investigators
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Principal Investigator: Amaan Mazhar, PhD Modulated Imaging Inc.
More Information
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Responsible Party: Modulated Imaging Inc.
ClinicalTrials.gov Identifier: NCT03563105    
Other Study ID Numbers: 900-0003
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Modulated Imaging Inc.:
tissue oxygen saturation