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Trial Title:
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
NCT ID:
NCT05748106
Condition:
Image-Guided Biopsies and/or Ablations
Conditions: Keywords:
Ultrasound Imaging
Interventional Radiology
Image-guided biopsy
Image-guided tumor ablation
Image-guided procedures
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Ultrasound-based imaging
Description:
Ultrasound-based imaging
Other name:
K3900
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.
Criteria for eligibility:
Study pop:
Any patient undergoing a standard / routine interventional radiologic procedure
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Undergoing standard / routine interventional radiologic procedure
Exclusion Criteria:
- Unwilling or unable to provide informed consent
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Texas Health Presbyterian Hospital
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Noah B Appel, MD
Phone:
214-345-7700
Email:
NoahAppel@texashealth.org
Investigator:
Last name:
Noah B Appel, MD
Email:
Principal Investigator
Start date:
February 15, 2023
Completion date:
June 30, 2023
Lead sponsor:
Agency:
MAUI Imaging, Inc.
Agency class:
Industry
Collaborator:
Agency:
Texas Health Resources
Agency class:
Other
Source:
MAUI Imaging, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05748106
