Image-Guided Biopsies and/or Ablations
Conditions
Keywords
Ultrasound Imaging, Interventional Radiology, Image-guided biopsy, Image-guided tumor ablation, Image-guided procedures
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.
Interventions
DEVICEUltrasound-based imaging
Ultrasound-based imaging
Sponsors
Texas Health Resources
MAUI Imaging, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Undergoing standard / routine interventional radiologic procedure
Exclusion criteria
* Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Countries
United States
Contacts
Primary ContactJohn C Cheronis, MD/PhD
Outcome results
None listed