NCT07012291 Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
| NCT ID | NCT07012291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Perosphere Technologies Inc. |
| Condition | Coagulation |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-06-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07012291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Coagulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07012291 currently recruiting?
Yes, NCT07012291 is actively recruiting participants. Contact the research team at s.bakhru@perospheretech.com for enrollment information.
Where is the NCT07012291 trial being conducted?
This trial is being conducted at Danbury, United States, Rockville, United States, Denville, United States, Cooperstown, United States.
Who is sponsoring the NCT07012291 clinical trial?
NCT07012291 is sponsored by Perosphere Technologies Inc.. The trial plans to enroll 150 participants.