NCT02191735

RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

Performance Evaluation of the RAMP® Cardiac Tests / RAMP® 200 in a Point-Of-Care Setting (C-POC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 719 (actual)
• Sponsor: Response Biomedical Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction
• Heart Failure
• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	RAMP 200	The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.
DEVICE	RAMP Reader	The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2014-07-16
• Last updated: 2015-01-08

Locations

3 sites across 1 country: United States