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Comparing a New 3D Technology Used to Measure Thyroid Nodule Volume to Standard Ultrasound

NCT07178080 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-17

No results posted yet for this study

Summary

After thyroid ablation procedure, the volume of the thyroid nodule (s) needs to be measured to see how well the procedure worked. Currently, these volumes are measured using traditional 2D ultrasound imaging. However, this approach comes with limitations because of the information 2D images cannot gather and because of differences in these measurements between different doctors. A new ultrasound technology called PIUR 3D imaging offers a novel alternative approach. The system uses advanced technology to create 3D images and can generate automated volume estimates. The PIUR imaging system, PIUR tUS Infinity, has been cleared by the Food and Drug Administration (FDA) to aid in treatment decisions when used alongside traditional 2D ultrasound imaging.

The purpose of this study is to test how effective and consistent the PIUR imaging technology is compared to standard 2D ultrasound in measuring thyroid nodule volume.

Conditions

  • Thyroid Nodules
  • Thyroid Nodule

Interventions

DEVICE

PIUR tUS Infinity Ultrasound

PIUR imaging technology, cleared by the U.S. Food and Drug Administration under 510(k) (K240036), is designed to provide advanced volumetric imaging capabilities to improve accuracy in assessing nodule size and volume reduction.

Sponsors & Collaborators

  • Sarasota Memorial Health Care System

    lead OTHER

Principal Investigators

  • Ralph Tufano, MD · Sarasota Memorial Health Care Systems

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2027-09-08
Completion
2027-09-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178080 on ClinicalTrials.gov