PAD - Peripheral Arterial Disease3D-USNCT05134311
Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies
A study testing PIUR tUS Imaging System in people with PAD - Peripheral Arterial Disease and Vascular Diseases, run by Northwell Health at 1 site in United States.
Trial summary
The ability to have a visual aid to depict areas of vascular disease that are affecting the patient's health can help in patient comprehension of the problem. This comprehension can lead to better understanding of the issue and increase patient compliance to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD - Peripheral Arterial Disease, Vascular Diseases, Wounds
- What is being tested?
- PIUR tUS Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older
- Suspected vascular insufficiency that requires ultrasound evaluation
- Subject is able to sign a consent form
- Scheduled ultrasound testing at the wound center to evaluate vasculature
Who cannot join
- Younger than 18 years old
- Subject is not scheduled to have ultrasound testing at the wound center
- Subject is unable to or refuses to consent to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health Comprehensive Wound Center
Lake Success, New York, 11042
Alisha Oropallo, MD, 516-233-3780, aoropallo@northwell.edu
Amit Rao, MD, 5162333671, arao3@northwell.edu
About this study
The ability to have a visual aid to depict areas of vascular disease that are affecting the patient's health can help in patient comprehension of the problem. This comprehension can lead to better understanding of the issue and increase patient compliance to treatment. The hand drawn sketch produced by the ultrasound technologist provides an inadequate visualization of the vascular insufficiency that is causing the patient's symptoms.
PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging. This system will provide a low cost and reproducible imaging solution that will be an effective educational tool for people with vascular disease.
Read the detailed description
Peripheral arterial disease (PAD) affects approximately 10% of the American population, with 30% to 40% of these patients presenting with claudication symptoms. The prevalence of PAD increases with age and the number of vascular risk factors. More importantly, it is a marker of atherosclerotic disease burden, and is associated with increased mortality from cardiovascular and cerebrovascular causes. There have been recent advances in noninvasive imaging, endovascular approaches for revascularization, and aggressive risk factor management for prevention of cardiac and cerebrovascular complications in PAD.
Ultrasound scanning imaging systems are currently the primary choice for vascular diagnostics. After a standard vascular study, the ultrasound technologist produces a handwritten sketch that highlights various parameters (vessel size and blood flow) throughout the vasculature in question. This sketch is then interpreted by the physician who then assesses and, if need be, performs interventions. This sketch is shown to the patient to better illustrate the vascular insufficiency issues that are affecting the patient. A digital copy of the sketch is also uploaded to the patient portal.
Due to a limited field of action and poor quantification accuracy, patients are often referred for secondary scanning procedures such as computed tomography angiography, magnetic resonance angiography and catheter angiography for more detailed imaging. Referrals delay treatment, expose the patient to potential health risks and pose higher costs to healthcare providers. This can lead to poor patient compliance and avoidable hospital readmissions. This presents a need to improve the rapidity and safety of the diagnosis of vascular conditions in patients to enable rapid treatment of conditions such as peripheral artery disease. There is also a need for cost effective preventative screening and surveillance to enable early intervention, for example, people at high risk of limb amputation.
The PIUR tUS Imaging System has been approved for use in the European Union for over 1 year. Studies performed in Europe have highlighted the system's ability to accurately depict various pathologies in a 3D form. Currently, there is no market equivalent of this technology approved by the FDA for use in the United States. We are conducting this study to determine whether the 3D images created by the device shown to patients can be used as an educational tool to increase patient comprehension of the disease process, compared with the standard of care 2D images. This will be measured in terms of compliance with follow-up appointments and 30-day readmission rates.
- Conditions
- PAD - Peripheral Arterial Disease, Vascular Diseases, Wounds
- Being tested
- PIUR tUS Imaging System
- Medical subject headings
- Vascular Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIUR tUS Imaging SystemDevice
PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging.
| Study group | Role | What they receive |
|---|---|---|
| 3D-US | Experimental | These subjects will have a 3D rendering of their vascular testing shown to them. Receives: Device: PIUR tUS Imaging System |
| Standard US | No intervention | These subjects will be shown a hand drawn sketch of the results of the vascular testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 Day re-admission
The primary endpoint of the study will be the treatment outcomes for the patients. We will review readmission rates (30 days from the day of the ultrasound) as well as compliance to first follow-up appointment after the ultrasound of interventional cohort. These endpoints will be compared to those of a historical cohort of persons who were treated for similar pathologies in the past.
Measured: 30 Days after imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Jul 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The primary analysis will compare the proportion of patients readmitted within 30 days of their ultrasound among those who received the 3D ultrasound vs. those who received the 2D ultrasound using a chi-square test. We will also compare the proportion of patients who showed up for their follow-up appointment among those who received the 3D ultrasound vs. those who received the 2D ultrasound using a chi-square test. We will assess for differences in baseline characteristics and factors known to be associated with readmission and compliance with follow-up among the two groups. If warranted, we will adjust for these differences using multivariable regression models.
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisha Oropallo, MD, Principal investigator, Northwell Health Comprehensive Wound Healing & Hyperbaric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134311
- Sponsor's protocol ID
- 20-1292-NHPP
- Acronym
- 3D-US
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rogers S, Carreira J, Phair A, Olech C, Ghosh J, McCollum C. Comparison Between Below Knee Contrast Enhanced Tomographic 3D Ultrasound and CT, MR or Catheter Angiography for Peripheral Artery Imaging. Eur J Vasc Endovasc Surg. 2021 Mar;61(3):440-446. doi: 10.1016/j.ejvs.2020.10.007. Epub 2020 Nov 20.
PubMed 33229220
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies
- ClinicalTrials.gov ID
- NCT05134311
- Acronym / sponsor ID
- 3D-US / 20-1292-NHPP
- Conditions
- PAD - Peripheral Arterial Disease, Vascular Diseases, Wounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ability to have a visual aid to depict areas of vascular disease that are affecting the patient's health can help in patient comprehension of the problem. This comprehension can lead to better understanding of the issue and increase patient compliance to treatment. The hand drawn sketch produced by the ultrasound technologist provides an inadequate visualization of the vascular insufficiency that is causing the patient's symptoms.
PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging. This system will provide a low cost and reproducible imaging solution that will be an effective educational tool for people with vascular disease.
Detailed description
Peripheral arterial disease (PAD) affects approximately 10% of the American population, with 30% to 40% of these patients presenting with claudication symptoms. The prevalence of PAD increases with age and the number of vascular risk factors. More importantly, it is a marker of atherosclerotic disease burden, and is associated with increased mortality from cardiovascular and cerebrovascular causes. There have been recent advances in noninvasive imaging, endovascular approaches for revascularization, and aggressive risk factor management for prevention of cardiac and cerebrovascular complications in PAD.
Ultrasound scanning imaging systems are currently the primary choice for vascular diagnostics. After a standard vascular study, the ultrasound technologist produces a handwritten sketch that highlights various parameters (vessel size and blood flow) throughout the vasculature in question. This sketch is then interpreted by the physician who then assesses and, if need be, performs interventions. This sketch is shown to the patient to better illustrate the vascular insufficiency issues that are affecting the patient. A digital copy of the sketch is also uploaded to the patient portal.
Due to a limited field of action and poor quantification accuracy, patients are often referred for secondary scanning procedures such as computed tomography angiography, magnetic resonance angiography and catheter angiography for more detailed imaging. Referrals delay treatment, expose the patient to potential health risks and pose higher costs to healthcare providers. This can lead to poor patient compliance and avoidable hospital readmissions. This presents a need to improve the rapidity and safety of the diagnosis of vascular conditions in patients to enable rapid treatment of conditions such as peripheral artery disease. There is also a need for cost effective preventative screening and surveillance to enable early intervention, for example, people at high risk of limb amputation.
The PIUR tUS Imaging System has been approved for use in the European Union for over 1 year. Studies performed in Europe have highlighted the system's ability to accurately depict various pathologies in a 3D form. Currently, there is no market equivalent of this technology approved by the FDA for use in the United States. We are conducting this study to determine whether the 3D images created by the device shown to patients can be used as an educational tool to increase patient comprehension of the disease process, compared with the standard of care 2D images. This will be measured in terms of compliance with follow-up appointments and 30-day readmission rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary analysis will compare the proportion of patients readmitted within 30 days of their ultrasound among those who received the 3D ultrasound vs. those who received the 2D ultrasound using a chi-square test. We will also compare the proportion of patients who showed up for their follow-up appointment among those who received the 3D ultrasound vs. those who received the 2D ultrasound using a chi-square test. We will assess for differences in baseline characteristics and factors known to be associated with readmission and compliance with follow-up among the two groups. If warranted, we will adjust for these differences using multivariable regression models.
| Arm | Type | Receives |
|---|---|---|
| 3D-US | Experimental | Device: PIUR tUS Imaging SystemThese subjects will have a 3D rendering of their vascular testing shown to them. |
| Standard US | No intervention | –These subjects will be shown a hand drawn sketch of the results of the vascular testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years of age or older
- Suspected vascular insufficiency that requires ultrasound evaluation
- Subject is able to sign a consent form
- Scheduled ultrasound testing at the wound center to evaluate vasculature
Key exclusion criteria (3 listed)
- Younger than 18 years old
- Subject is not scheduled to have ultrasound testing at the wound center
- Subject is unable to or refuses to consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIUR tUS Imaging SystemPIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging. | Device | 3D-US |
Primary outcome
30 Day re-admission
Time frame: 30 Days after imaging
The primary endpoint of the study will be the treatment outcomes for the patients. We will review readmission rates (30 days from the day of the ultrasound) as well as compliance to first follow-up appointment after the ultrasound of interventional cohort. These endpoints will be compared to those of a historical cohort of persons who were treated for similar pathologies in the past.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 33229220Rogers S, Carreira J, Phair A, Olech C, Ghosh J, McCollum C. Comparison Between Below Knee Contrast Enhanced Tomographic 3D Ultrasound and CT, MR or Catheter Angiography for Peripheral Artery Imaging. Eur J Vasc Endovasc Surg. 2021 Mar;61(3):440-446. doi: 10.1016/j.ejvs.2020.10.007. Epub 2020 Nov 20.
- Company website for 3D imaging deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for PAD - Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alisha Oropallo, MD principal investigator
Northwell Health Comprehensive Wound Healing & Hyperbaric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIUR tUS Imaging System in people with PAD - Peripheral Arterial Disease and Vascular Diseases, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha Oropallo, MD (516-233-3780, aoropallo@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 Day re-admission (time frame: 30 Days after imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05134311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.