Clinical Data Collection On Advanced CT System

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

Detailed 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.

Official Title
-----------------
Clinical Data Collection On Advanced CT System

Conditions
-----------------
CT Photon Counting

Intervention / Treatment
-----------------
* Device: Investigational Edge-on Silicon Photon Counting CT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 25 years of age or older; Able to sign and date the informed consent form; AND 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: Pregnant or lactating; 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; Need urgent or emergent care; 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 Are unwilling to have GEHC personnel present for the CT exam.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The single group model will enroll subjects for investigation CT scans of various anatomical areas (head, neck, heart, chest, abdomen, pelvis, and extremities) where data on the photon-counting CT is needed to evaluate image quality factors supporting diagnostic efficacy, support future regulatory submissions, assess clinical utility, and collect information on system performance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device. | Device: Investigational Edge-on Silicon Photon Counting CT device<br>* Administration of IV contrast material, if applicable, shall be done according to the hospital's SOC. Administration of oral contrast material, if applicable, shall also be done according to the hospital's SOC. Images will then be compared with the previously acquired CT conducted as standard of care. The investigational scan will take approximately 60-120 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | Raw investigational CT scan data along with standard of care raw CT scan data/images | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Information | Type and number of AEs and SAEs | 12 months | 
| Image Quality | Images created from the raw investigational CT scan data will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality) | 12 months |