Trials

ClotChip® is a class 2 medical device that has received FDA breakthrough device designation in March 2020, and is currently in clinical trials. A list of feasibility studies on the ClotChip® sensor include the following:

Pilot Studies

Phase I Clinical Study

Hypercoagulability in COVID-19 infections – Developing biomarkers of prognosis
University Hospitals of Cleveland
Status: open enrollment;
Sponsor: XaTek Inc.

Phase I Clinical Study

ClotChip® as a pre-surgical screening tool
University Hospitals of Cleveland
Status: open enrollment; N=100

Phase 2 Clinical Study

ClotChip® correlation to peak-trough blood concentration in both apixaban & rivaroxaban subjects
The U.S. Department of Veterans Affairs, Cleveland, OH
Status: enrollment closed; N = 24

Phase I Clinical Study

ClotChip® Sensitivity in Hemophilia – In Vivo & Ex Vivo analyses
University Hospitals of Cleveland – Rainbow Babies & Children Hospital, Cleveland, OH
Status: enrollment closed; N = 100

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