CT Photon CountingNCT05835284
Clinical Data Collection On Advanced CT System
An observational study of CT Photon Counting, run by GE Healthcare at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- CT Photon Counting
- What is being tested?
- Investigational Edge-on Silicon Photon Counting CT device
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 76 participants
- Where
- 1 siteSweden
- Study dates
- 4 Jun 2024to 19 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will consist of adults that are 25-years of age or older, and who have undergone prior clinically indicated CT examinations within the past 90 days of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and extremities. Images from prior standard of care diagnostic CT examinations of these subjects will also be collected.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
Read the detailed description
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.
- Conditions
- CT Photon Counting
- Being tested
- Investigational Edge-on Silicon Photon Counting CT device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device. Receives: Device: Investigational Edge-on Silicon Photon Counting CT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Raw investigational CT scan data along with standard of care raw CT scan data/images
Measured: 12 months
Secondary outcomes (2)
Safety Information
Type and number of AEs and SAEs
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start4 Jun 2024
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Photon CountingStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Brian W Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835284
- Sponsor's protocol ID
- 199254403
- Other IDs
- CIV-23-01-042048
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection On Advanced CT System
- ClinicalTrials.gov ID
- NCT05835284
- Acronym / sponsor ID
- 199254403
- Conditions
- CT Photon Counting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Device: Investigational Edge-on Silicon Photon Counting CT deviceEnrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of adults that are 25-years of age or older, and who have undergone prior clinically indicated CT examinations within the past 90 days of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and extremities. Images from prior standard of care diagnostic CT examinations of these subjects will also be collected.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Edge-on Silicon Photon Counting CT deviceAdministration 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. | Device | Single Arm |
Primary outcome
Data Collection
Time frame: 12 months
Raw investigational CT scan data along with standard of care raw CT scan data/images
2 secondary outcomes
Safety Information
Time frame: 12 months
Image Quality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Imaging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian W Thomsen study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Photon Counting, run by GE Healthcare at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.