Double Blinded, Randomized Clinical Trial of the Twin Star ECSPRESS Monitoring System for the Reduction of the Incidence of Fasciotomy (ECSPRESS)
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|ClinicalTrials.gov Identifier: NCT01879696|
Recruitment Status : Unknown
Verified June 2013 by Twin Star Medical, Inc..
Recruitment status was: Not yet recruiting
First Posted : June 18, 2013
Last Update Posted : June 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Compartment Syndrome||Device: ECSPRESS catheter with active vacuum||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Double Blinded Study for the Reduction of the Incidence of Fasciotomy|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||June 2015|
Treatment are subjects will have catheter vacuum active for the removal of fluid from the muscle compartment.
|Device: ECSPRESS catheter with active vacuum|
No Intervention: Control
Treatment are subjects will have catheter vacuum in-active for the removal of fluid from the muscle compartment.
- Incidence of fasciotomies [ Time Frame: End of study once all subjects have completed their 12 month follow-up interval. ]
- Area under the curve (AUC) for time-pressure [ Time Frame: End of study once all subjects have completed their 12 month follow-up interval. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879696
|Contact: David A Volgas, MDfirstname.lastname@example.org|
|Contact: James P Stannard, MDemail@example.com|
|United States, Missouri|
|University of Missouri-Columbia||Not yet recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Abigail K Stidham, LPN 573-882-7615 firstname.lastname@example.org|
|Principal Investigator: David Volgas, MD|