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The 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 |
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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.
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 Ablations | Device: 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.
| 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 |
- Device: Ultrasound-based imaging
Ultrasound-based imaging
Other Name: K3900
- 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?
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.
| Ages Eligible for Study: Â | Child, Adult, Older Adult |
| Sexes Eligible for Study: Â | All |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | 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
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
| 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 Â Â Â Â Â Â | |
MAUI Imaging, Inc.
Texas Health Resources
| Study Director: | John C Cheronis, MD/PhD | MAUI Imaging, Inc. |
| Responsible Party: | MAUI Imaging, Inc. |
| ClinicalTrials.gov Identifier: | NCT05748106 Â Â |
| Other Study ID Numbers: | 20203900a |
| First Posted: | February 28, 2023 Â Â Key Record Dates |
| Last Update Posted: | March 1, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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.
