Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03604029
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2018-07-18
Brief Title:
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
Sponsor:
Nonin Medical Inc
Organization:
Nonin Medical Inc
Study Overview
Official Title:
Evaluating the Diagnostic Performance of Near Infrared Spectroscopy NIRS in the Setting of Acute Compartment Syndrome ACS in Traumatized Lower Extremities
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
ENROLLING_BY_INVITATION
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:
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations
Detailed Description:
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations The name of this technology is NIRS near-infrared spectroscopy We have shown NIRS can be helpful in diagnosing ACS We think two of the primary advantages of this device are that it is noninvasive not painful and it collects data continuously so that if the disease develops it can be detected early and treated appropriately We have studied the capabilities of NIRS for many years The last step in the process of proving NIRS and its use in ACS will be to test our recommendations and guidelines The goal of this study is to test and prove our clinical guidelines we developed through previous work This is an interventional study which means the data we collect will be used to manage the patient and their care
Study Oversight
Has Oversight DMC:
None
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?:
None