Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies

NCT05134311 | Recruiting FDA Device

• 1 other identifier: 20-1292-NHPP
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PAD - Peripheral Arterial Disease; Vascular Diseases; Wounds

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Days after imaging

Study Arms (2)

3D-US

EXPERIMENTAL

These subjects will have a 3D rendering of their vascular testing shown to them.

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.

Interventions

PIUR tUS Imaging System DEVICE

PIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging.

3D-US

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health Comprehensive Wound Center

Lake Success, New York, 11042, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33229220 BACKGROUND

Related Links

• Company website for 3D imaging device

MeSH Terms

Conditions

Vascular Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Alisha Oropallo, MD

  Northwell Health Comprehensive Wound Healing & Hyperbaric Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha Oropallo, MD

CONTACT

516-233-3780; aoropallo@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 24, 2021
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)