Clinical Study of CT 5400 RT for System Validation

Not Applicable

Completed

• Conditions: Performance and Safety
• Interventions: Diagnostic Test: CT 5400 RT System

• Registration Number: NCT06466577
• Lead Sponsor: Philips Healthcare (Suzhou) Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Study Start: 2025-01-17
• Primary Completion: 2025-01-25
• Study Completion: 2025-02-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Image quality performance	CT 5400 RT System	-

Primary Outcome Measures

Name	Time	Method
Clinical image quality	14 days (anticipated)	Image quality will be assessed by Likert score (1-5)

Secondary Outcome Measures

Name	Time	Method
Convenience assessment	14 days (anticipated)	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.
Workflow and stability assessment	14 days (anticipated)	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.
General function assessment	14 days (anticipated)	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.
Incidence of CT Scan-Emergent Adverse Events	30 days (anticipated)	Monitor adverse events and serious adverse events(safety and tolerance) during the study

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China