NCT01756976

Clinical Evaluation of the OrthoPAT Advance System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Haemonetics Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.

Detailed description

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. * Hardware - * 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.

Conditions

• Transmission, Blood, Recipient/Donor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-12-28
• Last updated: 2013-11-20
• Results posted: 2013-11-20

Locations

1 site across 1 country: United States