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OpenTrials
Completed

NCT Number: NCT05835284

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.

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Key information

Conditions

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Solna, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Data Collection

    Time frame: 12 months

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

Secondary outcomes

  1. Safety Information

    Time frame: 12 months

    Type and number of AEs and SAEs

  2. Image Quality

    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)

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Karolinska University Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.