Next Generation CT System

Recruiting

• Conditions: Computed Tomography

• Registration Number: NCT06769594
• Lead Sponsor: GE Healthcare

Brief Summary

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.

Detailed Description

Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-04-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Subjects may be included in this study if they meet the following criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.

Exclusion Criteria

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; and,
7. Who are unwilling to have GEHC personnel present for the CT exam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data Collection	12 months	Number of investigational CT scans along with standard of care CT images

Secondary Outcome Measures

Name	Time	Method
Safety Information	12 months	Type and numbers of AEs, SAEs, and Device Deficiencies
Assessment of Image Quality	12 months	Images created from the raw investigational CT scan data will be scored for image quality

Trial Locations

Locations (1)

University of Wisconsin, Madison; 🇺🇸 Madison, Wisconsin, United States