Evaluating a new CT imaging device
Clinical Data Collection On Advanced CT System
This study is testing a new CT imaging device to see how well it captures images compared to standard CT scans for people who have had these exams recently.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | GE Healthcare Industry-sponsored |
| Locations | 1 site (Solna) |
| Trial ID | NCT05835284 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the investigational Edge-on Silicon Photon Counting CT device in a clinical environment. It involves collecting images from prior standard diagnostic CT exams of participants who have undergone these procedures within the last 90 days. The data gathered will support technology development, scientific evaluation, marketing, education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single-arm observational study conducted at a single site in Sweden.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 or older who have recently undergone a clinically indicated CT exam.
Not a fit: Patients who are pregnant, have allergies to iodinated contrast agents, or have renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to advancements in CT imaging technology, improving diagnostic accuracy and patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies evaluating advanced imaging technologies have shown promise in enhancing diagnostic capabilities.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Solna
- Karolinska University Hospital — Solna, Sweden (Recruiting)
Study contacts
- Study coordinator: Melissa Challman, MPH, CCRP
- Email: Melissa.Challman@ge.com
- Phone: 858-221-3007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.