Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities

NCT ID: NCT05748106

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Image-Guided Biopsies and/or Ablations

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound-based imaging

Ultrasound-based imaging

Intervention Type DEVICE

Other Intervention Names

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K3900

Eligibility Criteria

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Inclusion Criteria

* Undergoing standard / routine interventional radiologic procedure

Exclusion Criteria

* Unwilling or unable to provide informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Health Resources

OTHER

Sponsor Role collaborator

MAUI Imaging, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John C Cheronis, MD/PhD

Role: STUDY_DIRECTOR

MAUI Imaging, Inc.

Locations

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Texas Health Presbyterian Hospital

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John C Cheronis, MD/PhD

Role: CONTACT

3034354074

Facility Contacts

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Noah B Appel, MD

Role: primary

214-345-7700

Other Identifiers

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20203900a

Identifier Type: -

Identifier Source: org_study_id

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