Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

• Sponsor: MAUI Imaging, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05748106
• Collaborator: Texas Health Resources (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 4.4
• Patients Per Site Per Month: 11.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Image-Guided Biopsies and/or Ablations	Device: Ultrasound-based imaging

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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures
• Actual Study Start Date: Feb 15, 2023
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. 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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria:

• Unwilling or unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Health Presbyterian Hospital	Dallas	Texas	United States	75231

Sponsors and Collaborators

• MAUI Imaging, Inc.
• Texas Health Resources

Investigators

• Study Director: John C Cheronis, MD/PhD, MAUI Imaging, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MAUI Imaging, Inc.
• ClinicalTrials.gov Identifier: NCT05748106
• Other Study ID Numbers: 20203900a
• First Posted: Feb 28, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by MAUI Imaging, Inc.: Ultrasound Imaging; Interventional Radiology; Image-guided biopsy; Image-guided tumor ablation; Image-guided procedures

Study Results

No Results Posted as of Mar 1, 2023