Recruiting

Thromboembolism

Sponsor:

University of Arkansas

Code:

NCT05301348

Conditions

Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photoacoustic Flow Cytometry

Study Details

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.

Conditions

Thromboembolism

Study ID

NCT05301348

Start date

Jul 26, 2023

Status verified date

Feb, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • Informed consent provided by the subject.

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Procedure

Subjects will receive PAFC procedure

Interventions

Photoacoustic Flow Cytometry

Detection of circulating blood clots

Primary outcome measure

  • Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks [ Time Frame: 30 days ]
  • Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Sanjeeva Onteddu, MD

5016865135sronteddu@uams.edu

Locations

Univerisity of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Sanjeeva Onteddu, M.D.

501-686-5135sronteddu@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-02-19.