In Vivo Detection of Circulating Clots in Patients With Thromboembolism

Not Applicable

Recruiting

• Conditions: Thromboembolism
• Interventions: Device: Photoacoustic Flow Cytometry

• Registration Number: NCT05301348
• Lead Sponsor: University of Arkansas

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.

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.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-29
• Study Start: 2023-07-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure	Photoacoustic Flow Cytometry	Subjects will receive PAFC procedure

Primary Outcome Measures

Name	Time	Method
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks	30 days	Measurement of in vivo CBC-associated negative 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 - Positive PA peaks	30 days	Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods.

Secondary Outcome Measures

Name	Time	Method
Relationship between PA peaks and circulating blood clots	30 days	PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution.
Safety of the PAFC method - change in skin property	30 days	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
Safety of the PAFC method - skin sensitivity	30 days	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.

Trial Locations

Locations (1)

Univerisity of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States