Recruiting

PIUR Infinity tUS

Sponsor:

Northwell Health

Code:

NCT05134311

Conditions

PAD - Peripheral Arterial Disease

Vascular Diseases

Wounds

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PIUR tUS Imaging System

Study Details

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

Study ID

NCT05134311

Start date

Jul 1, 2025

Status verified date

Jun, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3D-US

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

no intervention: Standard US

These subjects will be shown a hand drawn sketch of the results of the vascular testing.

Interventions

PIUR tUS Imaging System

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

Primary outcome measure

  • 30 Day re-admission [ Time Frame: 30 Days after imaging ]

Central Contacts and Locations

Central contacts

Alisha Oropallo, MD

516-233-3780aoropallo@northwell.edu

Locations

Northwell Health Comprehensive Wound Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Alisha Oropallo, MD

516-233-3780aoropallo@northwell.edu

Amit Rao, MD

5162333671arao3@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-15.