Image-Guided Biopsies and/or AblationsNCT05748106
Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities
An observational study of Image-Guided Biopsies and/or Ablations, run by MAUI Imaging, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Image-Guided Biopsies and/or Ablations
- What is being tested?
- Ultrasound-based imaging
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient undergoing a standard / routine interventional radiologic procedure
Who may be able to join
- Undergoing standard / routine interventional radiologic procedure
Who cannot join
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Health Presbyterian Hospital
Dallas, Texas, 75231
Noah B Appel, MD, 214-345-7700, NoahAppel@texashealth.org
Noah B Appel, MD
About this study
Official title: Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures
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.
Read the 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.
- Conditions
- Image-Guided Biopsies and/or Ablations
- Being tested
- Ultrasound-based imaging
- Keywords
- Ultrasound Imaging, Interventional Radiology, Image-guided biopsy, Image-guided tumor ablation, Image-guided procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based imagingDevice
Also called K3900
Ultrasound-based imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Feb 2023
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image-Guided Biopsies and/or AblationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MAUI Imaging, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Health Resources
- Responsible party
- Sponsor
- Investigators
- John C Cheronis, MD/PhD, Study director, MAUI Imaging, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748106
- Sponsor's protocol ID
- 20203900a
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Ultrasound System Versus Standard Imaging Modalities in the Context of Interventional Radiologic Procedures
- ClinicalTrials.gov ID
- NCT05748106
- Acronym / sponsor ID
- 20203900a
- Conditions
- Image-Guided Biopsies and/or Ablations
- Keywords
- Ultrasound Imaging, Interventional Radiology, Image-guided biopsy, Image-guided tumor ablation, Image-guided procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MAUI Imaging, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Texas Health Resources
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient undergoing a standard / routine interventional radiologic procedure
Key inclusion criteria (1 listed)
- Undergoing standard / routine interventional radiologic procedure
Key exclusion criteria (1 listed)
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-based imagingAlso: K3900Ultrasound-based imaging | Device | – |
Primary outcome
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?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C Cheronis, MD/PhD study director
MAUI Imaging, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Image-Guided Biopsies and/or Ablations, run by MAUI Imaging, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John C Cheronis, MD/PhD (3034354074, john.cheronis@mauiimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usefulness relative to standard imaging for image-guided solid organ biopsies and/or ablations (time frame: Up to 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.