RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-06-20

Study Completion:2027-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07012291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Sasha Bakhru, PhD

CONTACT

475-218-4601

s.bakhru@perospheretech.com

Dardan Osmani, MS

CONTACT

475-218-4608

d.osmani@perospheretech.com

Study Locations (Sites)

Perosphere Technologies Inc

Danbury, Connecticut, 06811

United States

Perosphere Technologies Inc

Rockville, Maryland, 20850

United States

Eastern Vascular Associates

Denville, New Jersey, 07834

United States

Bassett Research Institute - Center for Clinical Research

Cooperstown, New York, 13326

United States

Collaborators and Investigators

Sponsor: Perosphere Technologies Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-20

Study Completion Date2027-06-01

Study Record Updates

Study Start Date2025-06-20

Study Completion Date2027-06-01

Terms related to this study

Additional Relevant MeSH Terms

Coagulation