Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
warningThe safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05748106
Recruitment Status : **RECRUITING NOW**

First Posted : February 28, 2023

Last Update Posted : March 1, 2023

Sponsor:

Collaborator:

Information provided by (Responsible Party):

MAUI Imaging, Inc.

Go to 

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.

Image-Guided Biopsies and/or AblationsDevice: 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.

Go to 

Layout table for study information
Study Type :Observational
Estimated 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 :February 15, 2023
Estimated Primary Completion Date :May 30, 2023
Estimated Study Completion Date :June 30, 2023
Resource links provided by the National Library of Medicine NIH NLM ABRV BLK 4

Go to 

Intervention Details:

  • Device: Ultrasound-based imaging

    Ultrasound-based imaging

    Other Name: K3900

Go to 

Primary Outcome Measures :

  1. Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations [ Time Frame: 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?

Go to 

Information from the National Library of Medicine NIH NLM ABRV BLK 4

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:  Child, Adult, Older Adult
Sexes Eligible for Study:  All
Accepts Healthy Volunteers:  No
Sampling Method:  Non-Probability Sample

Any patient undergoing a standard / routine interventional radiologic procedure

Inclusion Criteria:

  • Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
Go to 

Information from the National Library of Medicine NIH NLM ABRV BLK 4

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05748106

Layout table for location information
Texas Health Presbyterian Hospital
Dallas, Texas, United States, 75231
Contact: Noah B Appel, MD    214-345-7700    NoahAppel@texashealth.org   
Principal Investigator: Noah B Appel, MD         

MAUI Imaging, Inc.

Texas Health Resources

Layout table for investigator information
Study Director:John C Cheronis, MD/PhDMAUI Imaging, Inc.
Go to 

Layout table for additonal information
Responsible Party:MAUI Imaging, Inc.
ClinicalTrials.gov Identifier:NCT05748106    
Other Study ID Numbers:20203900a
First Posted:February 28, 2023    Key Record Dates
Last Update Posted:March 1, 2023
Last Verified:February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No

Layout table for additional information
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

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

March 2, 2023Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
Comments