Next Generation CT System

General Electric (GE)

Status: Enrolling

Conditions: Computed Tomography

Treatments: Device: Investigational CT Scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06769594

SA-000001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

General

Description:

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

Treatment:

Device: Investigational CT Scan

Cardiac

Description:

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

Treatment:

Device: Investigational CT Scan