Clinical Data Collection On Advanced CT System

General Electric (GE)

Status: Enrolling

Conditions: CT Photon Counting

Treatments: Device: Investigational Edge-on Silicon Photon Counting CT device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05835284

199254403

CIV-23-01-042048 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.

Full description

Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.

Enrollment: 120 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 25 years of age or older;
2. Able to sign and date the informed consent form; AND
3. Have undergone a clinically indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities where images are available within 90 days of investigational scanning.

Exclusion criteria

1. Pregnant or lactating;
2. 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. Need urgent or emergent care;
6. 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; OR
7. Are unwilling to have GEHC personnel present for the CT exam.

Trial design

120 participants in 1 patient group

Single Arm

Description:

Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device.

Treatment:

Device: Investigational Edge-on Silicon Photon Counting CT device