Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT05748106
Status:
UNKNOWN
Last Update Posted:
2023-03-01
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
Sponsor:
MAUI Imaging, Inc.
Organization:
Study Overview
Official Title:
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: