CT 5400 RT System Application Clinical Study

NCT06595888 | Completed

• 1 other identifier: 300200
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the satisfaction of the common functions, the operation convenience, and the whole system stability, and the safety of CT 5400 RT System.

Conditions

Computed Tomography Workflow Assessment

Outcome Measures

Primary Outcomes (3)

• the satisfaction of the common functions

  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.

  30 days (anticipated)

• the operation 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.

  30 days (anticipated)

• the system 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.

  30 days (anticipated)

Study Arms (1)

Computed Tomography

EXPERIMENTAL

Human subjects having CT scans

Radiation: Computed Tomography

Interventions

Computed Tomography RADIATION

X-ray by Computed Tomography

Computed Tomography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Philips Healthcare (Suzhou) Co., Ltd.: collaborator

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200120, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: March 14, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 18, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)