Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456268
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-08
Brief Title:
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction ACLR
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Clinical Evaluation of an External Neuromodulation Device VibraCool to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction ACLR
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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 goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction ACLR and thus residual opioids in circulation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None