Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures

This is an observational study comparing a novel ultrasound-based imaging system (MAUI K3900) to standard-of-care (SoC) imaging systems used to guide and/or manage interventional radiologic procedures such as solid organ biopsies or lesion ablations.

Study Overview

• Status: Recruiting
• Conditions: Image-Guided Biopsies and/or Ablations
• Intervention / Treatment: Device: Ultrasound-based imaging

Detailed Description

The purpose of this study is to obtain images using the MAUI Imaging Inc.'s K3900 Ultrasound System and compare them to images captured with FDA cleared imaging devices including traditional ultrasound, CT, MRI and Xray, and to study device safety. The information obtained in this study will inform MAUI Imaging as to what specific follow-on studies will be done in support of appropriate FDA clearances and/or claims. No diagnostic or patient management decisions will be made using the MAUI K3900 Ultrasound System in this study.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: John C Cheronis, MD/PhD; Phone Number: 3034354074; Email: john.cheronis@mauiimaging.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Texas Health Presbyterian Hospital
      • Contact: Noah B Appel, MD; Phone Number: 214-345-7700; Email: NoahAppel@texashealth.org
      • Principal Investigator: Noah B Appel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient undergoing a standard / routine interventional radiologic procedure

Description

Inclusion Criteria:

• Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria:

• Unwilling or unable to provide informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations	How does imaging with the K3900 compare with imaging currently used to guide solid organ biopsies or ablations, usually standard ultrasound, fluoroscopy, and/or CT?	Up to 26 weeks

Collaborators and Investigators

• Sponsor: MAUI Imaging, Inc.
• Collaborators: Texas Health Resources
• Investigators: Study Director: John C Cheronis, MD/PhD, MAUI Imaging, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Interventional Radiology; Ultrasound Imaging; Image-guided biopsy; Image-guided tumor ablation; Image-guided procedures
• Other Study ID Numbers: 20203900a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No