NCT05748106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 7, 2023

Last Update Submit

February 27, 2023

Conditions

Image-Guided Biopsies and/or Ablations

Keywords

Ultrasound ImagingInterventional RadiologyImage-guided biopsyImage-guided tumor ablationImage-guided procedures

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Ultrasound-based imagingDEVICE

Ultrasound-based imaging

Also known as: K3900

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient undergoing a standard / routine interventional radiologic procedure

You may qualify if:

  • Undergoing standard / routine interventional radiologic procedure

You may not qualify if:

  • Unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Health Presbyterian Hospital

Dallas, Texas, 75231, United States

RECRUITING

Study Officials

  • John C Cheronis, MD/PhD

    MAUI Imaging, Inc.

    STUDY DIRECTOR

Central Study Contacts

John C Cheronis, MD/PhD

CONTACT

3034354074john.cheronis@mauiimaging.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 28, 2023

Study Start

February 15, 2023

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)