Karolinska University Hospital
Solna, Sweden
NCT Number: NCT05835284
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
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Notify Me25 year and older
All sexes
Observational
Solna, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months
Raw investigational CT scan data along with standard of care raw CT scan data/images
Time frame: 12 months
Type and number of AEs and SAEs
Time frame: 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)
GE Healthcare
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.