Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT03563105
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Sponsor:
Modulated Imaging Inc.
Organization:
Study Overview
Official Title:
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: