Next Generation CT System

NCT06769594 | Completed FDA Device

• 1 other identifier: SA-000001
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Computed Tomography

Outcome Measures

Primary Outcomes (1)

• Data Collection

  Number of investigational CT scans along with standard of care CT images

  12 months

Secondary Outcomes (2)

• Safety Information

  12 months

• Assessment of Image Quality

  12 months

Study Arms (2)

General

Approximately 80 subjects whose standard of care imaging involved the head/neck, chest, abdomen/bowel and/or musculoskeletal regions will be enrolled.

Device: Investigational CT Scan

Cardiac

Approximately 20 subjects whose standard of care imaging involved the heart will be enrolled.

Device: Investigational CT Scan

Interventions

Investigational CT Scan DEVICE

All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.

Cardiac; General

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically indicated imaging exam of at least one of the following anatomical areas: head, neck, heart, chest, abdomen, pelvis, and/or extremities.

You may qualify if:

• Subjects may be included in this study if they meet the following criteria:
• Who are 18 year of age or older;
• Able to sign and date the informed consent form; AND
• 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.

You may not qualify if:

• Subjects may be excluded from participating in study if they meet any of the following criteria:
• Who are pregnant or lactating;
• Who were previously enrolled in this study;
• For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
• For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
• Who are in need of urgent or emergent care;
• 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,
• Who are unwilling to have GEHC personnel present for the CT exam.

Sponsors & Collaborators

• GE Healthcare: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

Location

Study Officials

• MICT Global Research Manager

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: April 8, 2025
• Primary Completion: March 6, 2026
• Study Completion: March 6, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)