NCT03563105

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 8, 2018

Last Update Submit

June 18, 2018

Conditions

Circulatory; Change

Keywords

tissue oxygen saturation

Outcome Measures

Primary Outcomes (1)

  • Significant decrease in StO2 during occlusion

    significant decrease in StO2 during occlusion

    immediate

Study Arms (1)

Desaturation

EXPERIMENTAL

Vascular Occlusion Test

Device: The Ox-Imager Mini (Desaturation)

Interventions

The Ox-Imager Mini (Desaturation)DEVICE

Vascular Occlusion Test

Desaturation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orange County Wound and Hyperbaric

Santa Ana, California, 92705, United States

Location

Study Officials

  • Amaan Mazhar, PhD

    Modulated Imaging Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Vascular Occlusion Test
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

May 30, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

US(1)