NCT05301348

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2023Jan 2027

First Submitted

Initial submission to the registry

February 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 26, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

February 9, 2022

Last Update Submit

February 18, 2026

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 days

  • 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.

    30 days

Secondary Outcomes (3)

  • Relationship between PA peaks and circulating blood clots

    30 days

  • Safety of the PAFC method - skin sensitivity

    30 days

  • Safety of the PAFC method - change in skin property

    30 days

Study Arms (1)

Procedure

EXPERIMENTAL

Subjects will receive PAFC procedure

Device: Photoacoustic Flow Cytometry

Interventions

Photoacoustic Flow CytometryDEVICE

Detection of circulating blood clots

Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Related Publications (9)

  • 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.

    PMID: 19411875BACKGROUND

  • 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.

    PMID: 22903924BACKGROUND

  • 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.

    PMID: 30460154BACKGROUND

  • 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.

    PMID: 17433897BACKGROUND

  • 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.

    PMID: 16102026BACKGROUND

  • 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.

    PMID: 2025141BACKGROUND

  • 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.

    PMID: 27227413BACKGROUND

  • 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.

    PMID: 21976458BACKGROUND

  • 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.

    PMID: 22749928BACKGROUND

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Sanjeeva Onteddu, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

  • Jonathan A Young

    University of Arkansas

    STUDY DIRECTOR

Central Study Contacts

Sanjeeva Onteddu, MD

CONTACT

5016865135sronteddu@uams.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 29, 2022

Study Start

July 26, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)