Clinical Data Collection On Advanced CT System

GE Healthcare76 enrolled

Overview

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

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

Conditions

CT Photon Counting

Interventions

Investigational Edge-on Silicon Photon Counting CT deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Locations (1)

Karolinska University Hospital

Solna, Sweden

Outcomes

Primary Outcomes

Data Collection

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

Time frame: 12 months

Secondary Outcomes

Safety Information

Type and number of AEs and SAEs

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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