Clinical Data Collection On Advanced CT System

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

Study Overview

• Status: Completed
• Conditions: CT Photon Counting
• Intervention / Treatment: Device: Investigational Edge-on Silicon Photon Counting CT device

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 Type: Observational
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Solna, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The subject population will consist of adults that are 25-years of age or older, and who have undergone prior clinically indicated CT examinations within the past 90 days of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and extremities. Images from prior standard of care diagnostic CT examinations of these subjects will also be collected.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Arm; 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; 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.

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Karolinska University Hospital
• Investigators: Study Director: Brian W Thomsen, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): February 19, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: 199254403; CIV-23-01-042048 (Other Identifier: Swedish Medical Products Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes