Examining the Use of Three Dimensional Ultrasound in the Assessment of Vascular Pathologies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
PIUR tUS Imaging System
DevicePIUR imaging has developed PIUR Infinity tUS, a 3D freehand tomographic ultrasound system capable of rapid, safe and accurate reconstructive 3D quantifiable vascular imaging.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: 3D-USExperimental treatment 1 intervention
Group B: Standard USNo intervention 0 interventions
Trial outcomes
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.
Time frame
30 Days after imagingSponsors and contacts
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Source ClinicalTrials.gov