Clinical Study of CT 5400 RT for System Validation

N/ACompletedNCT06466577

Philips Clinical & Medical Affairs Global36 enrolled

Overview

The purpose of this clinical trial is to evaluate the efficacy and safety of the CT 5400 RT System.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Performance and Safety

Interventions

CT 5400 RT SystemDIAGNOSTIC_TEST

Computed Tomography X-RAY System is intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18≤ Age ≤ 75 years old; * Subjects with Clear consciousness; Subjects can cooperate and act autonomously; * Subjects agree to participate in this clinical study and sign the subject's informed consent; * Women subjects of childbearing age should have a negative pregnancy test and should have no plans to become pregnant in the next 6 months. Exclusion Criteria: * Subjects who do not have full capacity for civil conduct; * Women subjects who are pregnant or in lactating phase; * Subjects who have had a CT scan within one year; * Subjects with a history of allergies or asthma, severe hepatic and renal insufficiency or hyperthyroidism in which are considered as contraindication for CT contrast-enhanced examination; * According to the opinion of the investigator: any situation that may affect the evaluation of the results or expose subjects into health risk; * Subjects with mental disorders who cannot cooperate with the examination

Locations (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Clinical image quality

Image quality will be assessed by Likert score (1-5)

Time frame: 14 days (anticipated)

Secondary Outcomes

General function assessment

A three-scale assessment will be used for Image exposure level, couch movement, speaker\& microphone voice quality, image post processing capability, data storage. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.

Time frame: 14 days (anticipated)

Convenience assessment

A three-scale assessment will be used for laser positioning, panel control, user-friendly interface of post-processing software, operation of post-processing software. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.

Time frame: 14 days (anticipated)

Workflow and stability assessment

A three-scale assessment will be used for workflow, Image display and transmission, system inactivation, unexpected system shutdown, unexpected termination during scanning, fail to expose during scanning A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.

Time frame: 14 days (anticipated)

Incidence of CT Scan-Emergent Adverse Events

Monitor adverse events and serious adverse events(safety and tolerance) during the study

Data from ClinicalTrials.gov

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