Clinical Study of CT 5400 RT for System Validation

Philips

Status: Completed

Conditions: Performance and Safety

Treatments: Diagnostic Test: CT 5400 RT System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06466577

200254

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Image quality performance

Other group

Treatment:

Diagnostic Test: CT 5400 RT System