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RECRUITING
NCT07012291

Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™

Sponsor: Perosphere Technologies Inc.

View on ClinicalTrials.gov

Summary

The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC). The instrument performs a whole blood clotting time (WBCT) test using freshly drawn, non-citrated whole blood. The purpose of the present study is to characterize the performance of the Perosphere ClotChek™ as a quantitative measurement of the WBCT in patients taking one of the following Direct Oral Anticoagulants (DOACs), rivaroxaban or apixaban.

Official title: Multi-site Clinical Performance Evaluation of Native Whole Blood Samples of Patients on Direct Oral Anticoagulants (DOACs) With the Perosphere ClotChek™ Coagulometer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2025-06-20

Completion Date

2027-06-01

Last Updated

2025-09-16

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Whole Blood Clotting Time

Fresh whole blood samples from patients on rivaroxaban or apixaban taken at various times during the day to obtain samples from DOAC patients that represent the entire analytical range to the extent possible, as opposed to a strict "trough/peak" testing schedule.

DEVICE

Whole Blood Clotting Time

Fresh whole blood samples, non-citrated, are drawn and loaded onto a cuvette free of any biological reagents, to obtain a whole blood clotting time value.

Locations (4)

Perosphere Technologies Inc

Danbury, Connecticut, United States

Perosphere Technologies Inc

Rockville, Maryland, United States

Eastern Vascular Associates

Denville, New Jersey, United States

Bassett Research Institute - Center for Clinical Research

Cooperstown, New York, United States