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Status unknownNCT03563105Updated Jun 20, 2018

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

An interventional study of The Ox-Imager Mini (Desaturation) in Circulatory; Change, sponsored by Modulated Imaging Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-20.

Sponsored by Modulated Imaging Inc. · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Circulatory; Change

Keywords

  • tissue oxygen saturation
03

In context

Lead sponsor

Modulated Imaging Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Over 18 years of age

Exclusion criteria

Exclusion Criteria:

  • History of congestive heart failure
  • Patients with existing wound or ulcer.
  • Rheumatoid arthritis
  • Pregnant or lactating women
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Desaturation

    Vascular Occlusion Test

    Device: The Ox-Imager Mini (Desaturation)

Interventions

  • DeviceThe Ox-Imager Mini (Desaturation)

    Vascular Occlusion Test

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What researchers measure

Primary outcomes

  1. Significant decrease in StO2 during occlusion

    significant decrease in StO2 during occlusion

    Time frame: immediate

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Study locations

1 site
  • Orange County Wound and Hyperbaric
    Santa Ana, California 92705, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03563105
Lead sponsor
Modulated Imaging Inc.
Responsible party
Sponsor
First posted
Jun 20, 2018
Start date
May 30, 2018
Primary completion
May 1, 2019 (estimated)
Completion
May 1, 2019 (estimated)
Last update
Jun 20, 2018

Study contacts

Amaan Mazhar, PhD
principal investigator · Modulated Imaging Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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