Comparison Between Below Knee Contrast Enhanced Tomographic 3D Ultrasound and CT, MR or Catheter Angiography for Peripheral Artery Imaging.
Steven Rogers, Joao Carreira, Alison Phair...
https://pubmed.ncbi.nlm.nih.gov/33229220/Actively Recruiting
Led by Northwell Health · Updated on 2026-06-15
270
Participants Needed
1
Research Sites
52 weeks
Total Duration
Peripheral arterial disease PAD and other vascular diseases affect a significant portion of the population and are linked to serious health risks including increased mortality from cardiovascular problems. Traditional imaging methods rely on handwritten sketches by ultrasound technologists, which may not clearly show vascular issues to patients, potentially limiting their understanding and compliance with treatment. This study evaluates the use of a new 3D ultrasound system to improve patient education and understanding of their vascular condition. The study compares two approaches one group of participants will have their vascular testing results shown as a 3D digital rendering using the PIUR Infinity tUS Imaging System, a device capable of rapid and accurate 3D vascular imaging. The other group will see the standard hand-drawn sketches currently used. This device is approved in Europe but is being studied here for its use as an educational tool in the United States. Participants will undergo scheduled ultrasound testing at a wound center, where their vascular health is evaluated. Researchers will track outcomes such as patient comprehension, compliance with follow-up appointments, and 30-day hospital readmission rates. The study aims to determine if the 3D imaging improves understanding and adherence to treatment plans compared to the standard sketches. The total duration of participation will depend on follow-up and monitoring over 30 days after imaging.
CONDITIONS
Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies
A
Alisha Oropallo, MD
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Northwell Health
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 3D Tomographic Ultrasound (PIUR Infinity tUS) | Standard 2D Ultrasound Imaging |
|---|---|---|
| What it is | A 3D freehand tomographic ultrasound system (PIUR Infinity tUS) designed to rapidly acquire volumetric vascular images for advanced assessment of peripheral arterial disease. | Conventional two-dimensional (2D) ultrasound imaging routinely used for non-invasive assessment of vascular structures and blood flow. |
| Role in trial | Investigational diagnostic device assessed for its ability to detect vascular pathologies in adults with suspected vascular disease. | Current standard imaging method used as the in-trial comparator for evaluating vascular insufficiency. |
| Primary use | Provides 3D vascular images to enhance detection and quantification of arterial abnormalities, aiming for a more comprehensive assessment than with standard 2D imaging. | Delivers 2D grayscale and Doppler images to assess peripheral blood vessels and identify vascular insufficiency. |
| How it is performed | Hand-held freehand 3D scan performed during scheduled wound center ultrasound, delivers tomographic vascular images in a single non-invasive session. | Standard noninvasive vascular ultrasound conducted by a trained technician during the participant's scheduled evaluation. |
| Evidence status | Ongoing clinical trial; published comparison studies suggest 3D tomographic ultrasound may improve visualization and quantification of vascular pathology, but large-scale clinical validation is in progress. | Longstanding accepted diagnostic pathway; broad literature supports standard 2D ultrasound for identifying and evaluating peripheral arterial disease, though with some recognized limitations in complex cases. |
| Important risks | Noninvasive imaging; no additional direct patient risk is reported beyond those associated with standard ultrasound imaging. | Noninvasive imaging method with a well-established safety profile and minimal risks, such as mild local discomfort during probe application. |
| Important limitations | Clinical trials to establish real-world effectiveness are ongoing; advanced 3D imaging may increase complexity and training requirements; evidence base is still maturing compared to standard imaging. | 2D vascular ultrasound may have limited visualization in some complex or calcified lesions, operator dependence, and lower accuracy in some peripheral sites compared to advanced three-dimensional or contrast-enhanced imaging. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days after imaging
Participants will undergo scheduled ultrasound testing at the wound center and be shown either a 3D digital image or a hand-drawn sketch of their vascular results.
1 baseline imaging visit and follow-up for 30-day readmission tracking
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Steven Rogers, Joao Carreira, Alison Phair...
https://pubmed.ncbi.nlm.nih.gov/33229220/Northwell Health
Lead Sponsor