Clinical Data Collection On Advanced CT System

Recruiting

• Conditions: CT Photon Counting
• Interventions: Device: Investigational Edge-on Silicon Photon Counting CT device

• Registration Number: NCT05835284
• Lead Sponsor: GE Healthcare

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.

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Status Verified: 2024-06
• Study Start: 2024-06-04
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Arm	Investigational Edge-on Silicon Photon Counting CT device	Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device.

Primary Outcome Measures

Name	Time	Method
Data Collection	12 months	Raw investigational CT scan data along with standard of care raw CT scan data/images

Secondary Outcome Measures

Name	Time	Method
Safety Information	12 months	Type and number of AEs and SAEs
Image Quality	12 months	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)

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Solna, Sweden