Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05301348

In Vivo Detection of Circulating Clots in Patients With Thromboembolism

Led by University of Arkansas · Updated on 2026-02-19

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a new device called Photoacoustic Flow Cytometry (PAFC) to detect circulating blood clots in patients with thromboembolic disease or those at high risk for such conditions. Current standard methods have limited sensitivity, especially when clot numbers in the blood are low, so this study aims to test whether PAFC can improve detection and potentially reduce complications from undetected clots. Participants will undergo the PAFC procedure, which is a novel imaging technique designed to identify clots in the bloodstream. The study does not involve comparison with other treatments but focuses on assessing the feasibility and safety of this device. The research includes monitoring for any skin sensitivity or changes related to the PAFC method over a 30-day period. During the study, patients will be evaluated through PAFC scans and blood tests measuring D-dimer levels, which are markers of clot presence. Researchers will compare clot detection results between PAFC and D-dimer tests and monitor any skin reactions. The trial involves a 30-day follow-up to assess safety and the relationship between PAFC signals and actual circulating clots. Participants will be closely observed but will continue to receive their usual care.

CONDITIONS

Brief Title

In Vivo Detection of Circulating Clots in Patients With Thromboembolism

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women, 18 years old and older
  • Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke
  • Informed consent provided by the subject
Not Eligible

You will not qualify if you...

  • Pulmonary embolus requiring mechanical ventilation or other ventilator support beyond oxygen by nasal cannula or mask at FiO2 ≤ 0.40
  • Acute coronary syndrome including unstable angina
  • Significant cardiac arrhythmia (except controlled atrial fibrillation)
  • Intracardiac thrombus
  • Embolus or thrombus requiring vascular surgery or interventional radiology for acute embolectomy or thrombectomy
  • Sickle cell disease with vaso-occlusive crisis
  • Sepsis or life-threatening infection
  • Traumatic injury requiring hospitalization within 30 days prior to enrollment
  • Pregnancy or breastfeeding
  • Severe mental illness
  • Other conditions deemed by investigators to increase subject risk

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 30 days

Participants undergo the Photoacoustic Flow Cytometry (PAFC) procedure to detect circulating blood clots.

1 procedure visit

Long-term Monitoring

Duration - Up to 30 days

Participants are monitored for safety and outcomes related to the PAFC procedure including skin sensitivity and skin property changes.

Follow-up assessments during the 30-day period

Trial Site Locations

Total: 1 location

1

Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

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Research Team

S

Sanjeeva Onteddu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Synergy of photoacoustic and fluorescence flow cytometry of circulating cells with negative and positive contrasts.

Dmitry A Nedosekin, Mustafa Sarimollaoglu, Ekaterina I Galanzha...

https://pubmed.ncbi.nlm.nih.gov/22903924

Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe.

Mazen A Juratli, Yulian A Menyaev, Mustafa Sarimollaoglu...

https://pubmed.ncbi.nlm.nih.gov/30460154

A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study.

F A Anderson, H B Wheeler, R J Goldberg...

https://pubmed.ncbi.nlm.nih.gov/2025141

In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts.

Ekaterina I Galanzha, Mustafa Sarimollaoglu, Dmitry A Nedosekin...

https://pubmed.ncbi.nlm.nih.gov/21976458