ClinicalTrials.gg
RecruitingNCT05301348Updated Feb 19, 2026

In Vivo Detection of Circulating Clots in Patients With Thromboembolism

An interventional study of Photoacoustic Flow Cytometry in Thromboembolism, sponsored by University of Arkansas. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by University of Arkansas · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.

Read the detailed description

There are no current gold standards to detect circulating blood clots. The sensitivity of most current methods to detect CBCs is poor when low numbers are present in the host. A novel method of detecting circulating blood clots, PAFC, may improve detection of CBCs and, if so, ultimately may reduce complications related to previously undetected clots.

02

Conditions studied

  • Thromboembolism

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03

In context

Thromboembolism

288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.

This study's planned enrollment of 30 is below the median of 173 across 155 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • provided by the subject.

Exclusion criteria

Exclusion Criteria

  • Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)
  • Acute coronary syndrome (including unstable angina)
  • Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)
  • Intracardiac thrombus
  • Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt 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 the investigators to put the subject at greater risk
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Procedure

    Subjects will receive PAFC procedure

    Device: Photoacoustic Flow Cytometry

Interventions

  • DevicePhotoacoustic Flow Cytometry

    Detection of circulating blood clots

06

What researchers measure

Primary outcomes

  1. Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks

    Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.

    Time frame: 30 days

  2. Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks

    Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods.

    Time frame: 30 days

Secondary outcomes

  1. Relationship between PA peaks and circulating blood clots

    PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution.

    Time frame: 30 days

  2. Safety of the PAFC method - skin sensitivity

    The safety of the PAFC device through estimation of the sensitivity of the individual's skin to laser radiation will be indicated by a possible warming feeling or tingling sensation.

    Time frame: 30 days

  3. Safety of the PAFC method - change in skin property

    The safety of the PAFC device through estimation of the change to the skin's property after laser exposure measured by appearance of possible red spots in the irradiated local area

    Time frame: 30 days

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Study locations

1 of 1 sites recruiting
  • Univerisity of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
    Recruiting
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References and documents

Publications

  • Dressler DK. Death by clot: acute coronary syndromes, ischemic stroke, pulmonary embolism, and disseminated intravascular coagulation. AACN Adv Crit Care. 2009 Apr-Jun;20(2):166-76. doi: 10.1097/NCI.0b013e3181a0b5e8. PubMed 19411875 ↗
  • Nedosekin DA, Sarimollaoglu M, Galanzha EI, Sawant R, Torchilin VP, Verkhusha VV, Ma J, Frank MH, Biris AS, Zharov VP. Synergy of photoacoustic and fluorescence flow cytometry of circulating cells with negative and positive contrasts. J Biophotonics. 2013 May;6(5):425-34. doi: 10.1002/jbio.201200047. Epub 2012 Aug 20. PubMed 22903924 ↗
  • Juratli MA, Menyaev YA, Sarimollaoglu M, Melerzanov AV, Nedosekin DA, Culp WC, Suen JY, Galanzha EI, Zharov VP. Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe. Biomed Opt Express. 2018 Oct 23;9(11):5667-5677. doi: 10.1364/BOE.9.005667. eCollection 2018 Nov 1. PubMed 30460154 ↗
  • Cushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol. 2007 Apr;44(2):62-9. doi: 10.1053/j.seminhematol.2007.02.004. PubMed 17433897 ↗
  • Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x. PubMed 16102026 ↗
  • Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8. PubMed 2025141 ↗
  • Juratli MA, Menyaev YA, Sarimollaoglu M, Siegel ER, Nedosekin DA, Suen JY, Melerzanov AV, Juratli TA, Galanzha EI, Zharov VP. Real-Time Label-Free Embolus Detection Using In Vivo Photoacoustic Flow Cytometry. PLoS One. 2016 May 26;11(5):e0156269. doi: 10.1371/journal.pone.0156269. eCollection 2016. PubMed 27227413 ↗
  • Galanzha EI, Sarimollaoglu M, Nedosekin DA, Keyrouz SG, Mehta JL, Zharov VP. In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts. Cytometry A. 2011 Oct;79(10):814-24. doi: 10.1002/cyto.a.21106. Epub 2011 Aug 16. PubMed 21976458 ↗
  • Galanzha EI, Zharov VP. Photoacoustic flow cytometry. Methods. 2012 Jul;57(3):280-96. doi: 10.1016/j.ymeth.2012.06.009. Epub 2012 Jun 26. PubMed 22749928 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.

Of 20 interventional studies with no phase under Thromboembolism, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 146. This study's planned 41 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2022
First posted
Mar 29, 2022
StartActual
Jul 26, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jan 31, 2027
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05301348
Responsible party
Sponsor
First posted
Mar 29, 2022
Start date
Jul 26, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Feb 19, 2026

Study contacts

Sanjeeva Onteddu, MD
Contact
sronteddu@uams.edu
5016865135
Sanjeeva Onteddu, MD
principal investigator · University of Arkansas
Jonathan A Young
study director · University of Arkansas

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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