Clinical Data Collection On Advanced CT System

Sponsor

GE Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05835284

Collaborator

Karolinska University Hospital (Other)

120

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
CT Photon Counting	Device: Investigational Edge-on Silicon Photon Counting CT device	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The single group model will enroll subjects for investigation CT scans of various anatomical areas (head, neck, heart, chest, abdomen, pelvis, and extremities) where data on the photon-counting CT is needed to evaluate image quality factors supporting diagnostic efficacy, support future regulatory submissions, assess clinical utility, and collect information on system performance.The single group model will enroll subjects for investigation CT scans of various anatomical areas (head, neck, heart, chest, abdomen, pelvis, and extremities) where data on the photon-counting CT is needed to evaluate image quality factors supporting diagnostic efficacy, support future regulatory submissions, assess clinical utility, and collect information on system performance.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical Data Collection On Advanced CT System

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device.	Device: Investigational Edge-on Silicon Photon Counting CT 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.

Arm

Intervention/Treatment

Experimental: Single Arm

Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device.

Device: Investigational Edge-on Silicon Photon Counting CT 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.

Outcome Measures

Primary Outcome Measures

Data Collection [12 months]
Raw investigational CT scan data along with standard of care raw CT scan data/images

Secondary Outcome Measures

Safety Information [12 months]
Type and number of AEs and SAEs
Image Quality [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

GE Healthcare
Karolinska University Hospital

Investigators

Study Director: Brian W Thomsen, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GE Healthcare

ClinicalTrials.gov Identifier:

NCT05835284

Other Study ID Numbers:

199254403
CIV-23-01-042048

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Silicon

Study Results

No Results Posted as of Apr 28, 2023