Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

MAUI Imaging

Status: Enrolling

Conditions: Image-Guided Biopsies and/or Ablations

Treatments: Device: Ultrasound-based imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05748106

20203900a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing standard / routine interventional radiologic procedure

Exclusion criteria

• Unwilling or unable to provide informed consent