Assessment of Circulatory Compromise With Ox-Imager Using... | NCT03563105

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

NCT03563105

Sponsor

Modulated Imaging Inc.

Status

Unknown status

Last Update Posted

Jun 20, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Circulatory; Change

Interventions

The Ox-Imager Mini (Desaturation)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2018Actual

Primary Completion Date

May 1, 2019Estimated

Completion Date

May 1, 2019Estimated

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Jun 18, 2018

First Posted Date

Jun 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2018

Last Update Posted Date

Jun 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desaturation	Experimental	Vascular Occlusion Test	Device: The Ox-Imager Mini (Desaturation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Ox-Imager Mini (Desaturation)	Device	Vascular Occlusion Test	Desaturation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Significant decrease in StO2 during occlusion	significant decrease in StO2 during occlusion	immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amaan Mazhar, PhD	Modulated Imaging Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orange County Wound and Hyperbaric		Santa Ana	California	92705	United States