Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-11 @ 9:28 PM
Study NCT ID:
NCT04197505
Status:
WITHDRAWN
Last Update Posted:
2021-10-11
First Post:
2019-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Application of Forward-looking Infrared for the Identification and Evaluation of Fractures in the Acute Trauma Setting
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lost funding due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of this study is to (1) determine whether thermal imaging can be used during an acute trauma patient's secondary or tertiary survey to identify injury sites with an underlying fracture, and to (2) investigate whether thermal imaging can predict those patients whose fractures will result in a non-union.
Detailed Description:
Human subjects will be enrolled into the study from NYU Langone Health and Bellevue Hospital Center. When orthopaedic surgery is consulted for management of a fracture, the patient will be offered enrollment into the study. The collected data will be assigned a letter and number associated for references with the patient's age, type of fracture, and time since original injury to thermal imaging scan. If any patient receives a thermal imaging scan at their initial injury evaluation, then he or she will also receive thermal imaging scans at all follow-up appointments to track changes in temperature over the healing process. No obtunded or unresponsive patients will be enrolled into the study. The goal will be to have to thirty patients enrolled into both acute fracture and non-union arms of the proposal for a total of sixty subjects. Age, gender, ethnicity, smoking status, medical history, and surgical history will be recorded for future confounding analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: