Clinical Evaluation of the OrthoPAT Advance System
This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Evaluation of the OrthoPAT Advance System|
- Washed RBC Hematocrit [ Time Frame: < 4 hours ] [ Designated as safety issue: No ]The Hematocrit of the RBC shall be > 50%.
|Study Start Date:||December 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
Device: OrthoPat Advance
The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
The OrthoPAT Advance system is being developed by Haemonetics to change the user interface, especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as the predicate device. The following items will be changed in the OrthoPAT Advance system compared to OrthoPAT:
- Software & User Interface - ability to enter irrigant and anti-coagulant volumes and allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance.
- Redesign of reservoir and filter to process blood earlier by reducing hold-up volume and improve fluid visualization in reservoir.
- Extended battery life.
It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir / filter and EBL), which will be conducted as lab based tests. The correct functioning of the reservoir / filter and EBL changes will be confirmed in the clinical setting in this study. However the most rigorous challenge to the filter will be by presenting the worst case media and this can only be controlled in the laboratory.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756976
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Jonathan Waters, MD||University of Pittsburgh Medial Center|