NCT07012291

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Perosphere Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coagulation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-06-10
• Last updated: 2025-09-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study