Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
- Conditions
- Image-Guided Biopsies and/or Ablations
- Registration Number
- NCT05748106
- Lead Sponsor
- MAUI Imaging, Inc.
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Undergoing standard / routine interventional radiologic procedure
- Unwilling or unable to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations Up to 26 weeks 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?
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Texas Health Presbyterian Hospital
🇺🇸Dallas, Texas, United States