Comparison of a Novel Ultrasound System Versus Standard I... | NCT05748106

Studies
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

NCT05748106

Sponsor

MAUI Imaging, Inc.

Status

Unknown status

Last Update Posted

Mar 1, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Image-Guided Biopsies and/or Ablations

Interventions

Ultrasound-based imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2023Actual

Primary Completion Date

May 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Feb 7, 2023

First Submission Date that Met QC Criteria

Feb 17, 2023

First Posted Date

Feb 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Mar 1, 2023Actual

Name	Class
Texas Health Resources	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound-based imaging	Device	Ultrasound-based imaging		K3900

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations	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?	Up to 26 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria:

Unwilling or unable to provide informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Any patient undergoing a standard / routine interventional radiologic procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John C Cheronis, MD/PhD	Contact	3034354074		john.cheronis@mauiimaging.com

Overall Officials

Name	Affiliation	Role
John C Cheronis, MD/PhD	MAUI Imaging, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Texas Health Presbyterian Hospital	Recruiting	Dallas	Texas	75231	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided