Clinical Study of CT 5400 RT for System Validation

NCT06466577 | Completed

• 1 other identifier: 200254
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Performance and Safety

Outcome Measures

Primary Outcomes (1)

• Clinical image quality

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

  14 days (anticipated)

Secondary Outcomes (4)

• General function assessment

  14 days (anticipated)

• Convenience assessment

  14 days (anticipated)

• Workflow and stability assessment

  14 days (anticipated)

• Incidence of CT Scan-Emergent Adverse Events

  30 days (anticipated)

Study Arms (1)

Image quality performance

OTHER

Diagnostic Test: CT 5400 RT System

Interventions

CT 5400 RT System DIAGNOSTIC_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.

Image quality performance

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: June 20, 2024
• Study Start: January 17, 2025
• Primary Completion: January 25, 2025
• Study Completion: February 20, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)