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

Part of paid clinical trials in Danbury, Connecticut.

Sponsor
Perosphere Technologies Inc.
Study ID
NCT07012291
Status
Recruiting
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Conditions

  • Coagulation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Whole Blood Clotting Time — DEVICE
    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.
  • Whole Blood Clotting Time — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 20, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Differentiating DOAC patients taking rivaroxaban or apixaban from normal control patients, via measurement of their whole blood clotting time. [ Time Frame: Day 1 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Perosphere Technologies IncDanburyConnecticut06811
Dardan Osmani, MS
[email protected]
4752184608
Anita Balaj, MS
[email protected]
475-218-4672
Sasha Bakhru, PhD (PRINCIPAL_INVESTIGATOR)
Perosphere Technologies IncRockvilleMaryland20850
Lirong Chen, PhD
[email protected]
240-872-0152
Anita Balaj, MS
[email protected]
475-218-4672
Xuan Jiang, PhD (PRINCIPAL_INVESTIGATOR)
Eastern Vascular AssociatesDenvilleNew Jersey07834
Dardan Osmani, MS
[email protected]
475-218-4608
Anita Balaj, MS
[email protected]
475-218-4672
Bruce Mintz, DO (PRINCIPAL_INVESTIGATOR)
Bassett Research Institute - Center for Clinical ResearchCooperstownNew York13326
Dardan Osmani, MS
[email protected]
475-218-4608
Anita Balaj, MS
[email protected]
475-218-4672
Anush Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Perosphere Technologies Inc· Danbury, CTPerosphere Technologies Inc· Rockville, MDEastern Vascular Associates· Denville, NJBassett Research Institute - Center for Clinical Research· Cooperstown, NY

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