Clinical Study of CT 5400 RT for System Validation

NCT ID: NCT06466577

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-17

Study Completion Date

2025-02-20

Brief Summary

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

Detailed Description

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Conditions

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Performance and Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Image quality performance

Group Type OTHER

CT 5400 RT System

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Healthcare (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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200254

Identifier Type: -

Identifier Source: org_study_id

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