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Device
Photoacoustic Detection for Blood Clots
N/A
Recruiting
Led By Sanjeeva Onteddu, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial is testing a device to see if it can detect blood clots in people who are at high risk for them.
Who is the study for?
This trial is for adults over 18 with thromboembolic disease, confirmed by standard tests like ultrasound. It's not for those needing acute embolectomy/thrombectomy, with unstable heart conditions, intracardiac clots, pregnant/breastfeeding women, severe infections or mental illness, recent trauma patients or those on certain ventilator support.Check my eligibility
What is being tested?
The study is testing the feasibility of a new device that uses Photoacoustic Flow Cytometry to detect circulating blood clots in vivo in patients who have or are at high risk for thromboembolism.See study design
What are the potential side effects?
Since this trial involves a non-invasive detection device rather than medication, traditional side effects related to drugs may not apply. However, potential risks associated with the procedure will be explained by the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a blood clot or stroke recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks
Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks
Secondary outcome measures
Relationship between PA peaks and circulating blood clots
Safety of the PAFC method - change in skin property
Safety of the PAFC method - skin sensitivity
Trial Design
1Treatment groups
Experimental Treatment
Group I: ProcedureExperimental Treatment1 Intervention
Subjects will receive PAFC procedure
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,323 Total Patients Enrolled
Sanjeeva Onteddu, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
24 Total Patients Enrolled
Jonathan A YoungStudy DirectorUniversity of Arkansas
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a blood clot or stroke recently.I have had a clot removed through surgery or a special procedure.I am 18 years old or older.I have a heart rhythm problem but it's controlled with medication.I have had a recent heart attack or unstable chest pain.I have a blood clot in my heart.I have sickle cell disease and experience pain crises.You have been in the hospital for a serious injury within the last 30 days.The researchers think you might be at higher risk because of other health conditions.I need a ventilator due to a lung clot, but may only use oxygen through a mask or nasal tube.I am currently experiencing a severe infection.You have a serious mental illness.
Research Study Groups:
This trial has the following groups:- Group 1: Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for individuals to join this research trial?
"Clinicaltrials.gov confirms that this trial is currently recruiting volunteers, with the initial posting on February 1st 2023 and a recent modification to the listing made on November 28th 2022."
Answered by AI
What is the cap on the number of participants in this experiment?
"Affirmative, the clinical trial details on clinicaltrials.gov demonstrate that this medical study is currently recruiting participants. This experimental protocol was first shared on February 1st 2023 and most recently revised on November 28th 2022. The research team has space for 30 volunteers across a single site."
Answered by AI
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