Clinical Study of CT 5400 RT for System Validation

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

Study Overview

• Status: Not yet recruiting
• Conditions: Performance and Safety
• Intervention / Treatment: Diagnostic test: CT 5400 RT System

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Image quality performance	Diagnostic test: CT 5400 RT System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical image quality	Image quality will be assessed by Likert score (1-5)	14 days (anticipated)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	14 days (anticipated)
Incidence of CT Scan-Emergent Adverse Events	Monitor adverse events and serious adverse events(safety and tolerance) during the study	30 days (anticipated)

Collaborators and Investigators

• Sponsor: Philips Healthcare (Suzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 28, 2024
• Primary Completion (Estimated): September 28, 2024
• Study Completion (Estimated): September 28, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Estimated): June 19, 2024

Study Record Updates

• Last Update Posted (Estimated): June 19, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 200254

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No