Recruiting

Perosphere ClotChek™

Sponsor:

Perosphere Technologies Inc.

Code:

NCT07012291

Conditions

Coagulation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Whole Blood Clotting Time

Whole Blood Clotting Time

Study Details

Brief 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

Study ID

NCT07012291

Start date

Jun 20, 2025

Status verified date

Jun, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
  • Be 18- to 80-years-of-age, inclusive, at time of consent.
  • Have suitable venous access for at least a single venipuncture.
  • Eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion
  • Eligible patients on anticoagulants must have been on their anticoagulant therapy for at least one month.

Exclusion Criteria:

  • Have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions, other than the condition for which a DOAC was prescribed.
  • Have a history of unexplained syncope.
  • Have a history within six months prior to Screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding).
  • Consume more than five cigarettes per day.
  • If female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy).
  • If female, be pregnant, breastfeeding, or planning to become pregnant during the study.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

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.

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 and Locations

Central contacts

Sasha Bakhru, PhD

475-218-4601s.bakhru@perospheretech.com

Dardan Osmani, MS

475-218-4608d.osmani@perospheretech.com

Locations

Perosphere Technologies Inc

Recruiting

Danbury, Connecticut, United States, 06811

Contacts

Dardan Osmani, MS

4752184608d.osmani@perospheretech.com

Anita Balaj, MS

475-218-4672a.balaj@perospheretech.com

Principal Investigator:

Sasha Bakhru, PhD

Perosphere Technologies Inc

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Lirong Chen, PhD

240-872-0152l.chen@perospheretech.com

Anita Balaj, MS

475-218-4672a.balaj@perospheretech.com

Principal Investigator:

Xuan Jiang, PhD

Eastern Vascular Associates

Recruiting

Denville, New Jersey, United States, 07834

Contacts

Dardan Osmani, MS

475-218-4608d.osmani@perospheretech.com

Anita Balaj, MS

475-218-4672a.balaj@perospheretech.com

Principal Investigator:

Bruce Mintz, DO

Bassett Research Institute - Center for Clinical Research

Recruiting

Cooperstown, New York, United States, 13326

Contacts

Dardan Osmani, MS

475-218-4608d.osmani@perospheretech.com

Anita Balaj, MS

475-218-4672a.balaj@perospheretech.com

Principal Investigator:

Anush Patel, MD

More Information

Sponsor

Perosphere Technologies Inc.

Last update posted

Sep 16, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Perosphere Technologies Inc. on 2025-09-16.