CompletedNot Applicable

Clinical Data Collection On Advanced CT System

Sweden76 participantsStarted 2024-06-04

Plain-language summary

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

Age range25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Data Collection

Timeframe: 12 months

NCT IDNCT05835284

SponsorGE Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-19