Spectral CT Clinical Trial Protocol

Not Applicable

Terminated

• Conditions: CT Scanning
• Interventions: Device: Spectral CT

• Registration Number: NCT05017233
• Lead Sponsor: Philips (China) Investment CO., LTD

Brief Summary

The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT

Detailed Description

Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

Study Timeline

• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-23
• Study Start: 2022-07-04
• Primary Completion: 2022-11-01
• Study Completion: 2023-02-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Recruit volunteers (ages 18 to 75);
• Negative pregnancy tests in women of childbearing age;
• Participants who agree to participate in this clinical trial and sign the informed consent;
• Enhanced scans require laboratory tests to confirm normal renal function.

Exclusion Criteria

• Persons who do not have full capacity for civil conduct;
• Lactating women;
• People who are not suitable for enhanced scanning with iodine contrast agent;
• Patients whom the investigator considers inappropriate to participate in this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group, all volunteer will be scanned.	Spectral CT	All participation accept Spectral CT scanning; No group;

Primary Outcome Measures

Name	Time	Method
Excellent and good rate of clinical imaging (score≥3）	through study completion, an average of 1 year	Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory

Secondary Outcome Measures

Name	Time	Method
Common functions assessment	through study completion, an average of 1 year	Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied
Convenience evaluation assessment	through study completion, an average of 1 year	Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied
Machine function and stability assessment	through study completion, an average of 1 year	Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied
Adverse events and serious adverse events	through study completion, an average of 1 year	Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.

Trial Locations

Locations (3)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China

Ruijin Hospital; 🇨🇳 Shanghai, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China