Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT07012291

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

Led by Perosphere Technologies Inc. · Updated on 2025-09-16

150

Participants Needed

4

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent before any study procedures
  • Be between 18 and 80 years old at time of consent
  • Have suitable venous access for at least one venipuncture
  • Have taken prescribed anticoagulants regularly for at least one month prior to participation
  • Be on anticoagulant therapy for at least one month
Not Eligible

You will not qualify if you...

  • Have personal or family history of clotting disorders or blood abnormalities such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or chronic conditions requiring transfusions other than for DOAC treatment
  • Have history of unexplained fainting (syncope)
  • Have had peptic ulcer or gastrointestinal bleeding within six months before screening
  • Smoke more than five cigarettes per day
  • If female, have history of excessive or dysfunctional uterine bleeding unless having had a hysterectomy
  • If female, be pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Perosphere Technologies Inc

Danbury, Connecticut, United States, 06811

Actively Recruiting

2

Perosphere Technologies Inc

Rockville, Maryland, United States, 20850

Actively Recruiting

3

Eastern Vascular Associates

Denville, New Jersey, United States, 07834

Actively Recruiting

4

Bassett Research Institute - Center for Clinical Research

Cooperstown, New York, United States, 13326

Actively Recruiting

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Research Team

S

Sasha Bakhru, PhD

CONTACT

D

Dardan Osmani, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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