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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Sarasota Memorial Health Care System
Study ID
NCT07178080
Status
Enrolling By Invitation

Conditions

  • Thyroid Nodule
  • Thyroid Nodules

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PIUR tUS Infinity Ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 8, 2025
Status verified
Sep 2025
Primary completion
Sep 8, 2027
Completion
Sep 8, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 3D ultrasound using PIUR tUS Infinity
    Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another.
  • Other: Traditional 2D
    Both imaging methods will be used throughout the study, the traditional 2D ultrasound followed by the 3D ultrasound using PIUR tUS Infinity. Volume measurements from each imaging method will be compared to one another.

Primary Outcome Measure

Thyroid nodule volumetric measurements [ Time Frame: Will occur at baseline, 2 weeks, 1 month, 3 months, 6 months, and 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarasota Memorial Health Care SystemSarasotaFlorida34239-

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Sarasota Memorial Health Care System· Sarasota, FL

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