Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-04 @ 7:02 PM
Study NCT ID:
NCT02379104
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2015-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
Sponsor:
Tem Innovations GmbH
Organization:
Study Overview
Official Title:
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
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:
ROSI-EVA
Brief Summary:
ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.
Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.
Confirmation of reference intervals of the ROTEM® systems.
Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.
Confirmation of reference intervals of the ROTEM® systems.
Detailed Description:
The main innovation of ROTEM® sigma is the development of a sample handler and a cartridge allowing for a of full automated test operation. As in ROTEM® delta four different tests can be run simultaneously on the four channels of the analyser.
Whereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.
The five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:
* Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM
* Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM
Aim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.
As a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.
Whereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.
The five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:
* Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM
* Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM
Aim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.
As a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.
Study Oversight
Has Oversight DMC:
True
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?: