NCT05301348 · University of Arkansas
In Vivo Detection of Circulating Clots in Patients With Thromboembolism
What this study is about
Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other the usual treatment techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.
View original scientific description
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.
Interventions
DEVICE
Photoacoustic Flow Cytometry
Detection of circulating blood clots
Primary outcome measures
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
Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.
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
Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Little Rock, Arkansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations