Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-14 @ 9:01 PM
Study NCT ID:
NCT01965561
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance of Junctional Tourniquets in Normal Human Volunteers
Sponsor:
United States Army Institute of Surgical Research
Organization:
Study Overview
Official Title:
Performance of Junctional Tourniquets in Normal Human Volunteers
Status:
COMPLETED
Status Verified Date:
2017-11
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:
Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.
Detailed Description:
Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: