Clinical Data Collection On Advanced CT System

NCT05835284 | Completed FDA Device

• 2 other identifiers: 199254403CIV-23-01-042048
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CT Photon Counting

Outcome Measures

Primary Outcomes (1)

• Data Collection

  Raw investigational CT scan data along with standard of care raw CT scan data/images

  12 months

Secondary Outcomes (2)

• Safety Information

  12 months

• Image Quality

  12 months

Study Arms (1)

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

Interventions

Investigational Edge-on Silicon Photon Counting CT device 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.

Single Arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Solna, Sweden

Location

Study Officials

• Brian W Thomsen

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: June 4, 2024
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)