Clinical Data Collection On Advanced CT System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-04

Study Completion Date

2026-03-31

Brief Summary

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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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Detailed Description

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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

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CT Photon Counting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

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

Investigational Edge-on Silicon Photon Counting CT device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No