Incisive CT Clinica Trial Protocol

NCT05020262 | Unknown FDA Drug FDA Device

• 1 other identifier: PD_CT_Incisive CT_2021_11264
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate whether the new features of Incisive CT: Precise Image, (PI) and Precise Cardiac (PC) had the expected effectiveness

Conditions

CT Images

Outcome Measures

Primary Outcomes (1)

• The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score

  Scoring criteria 5 points The image quality of PI/PC is better than that of iDose4/ cardiac imaging, which can be used for diagnosis, very satisfied 4 points The image quality of PI/PC is better than that of contrast products, and the image of iDose4/ cardiac imaging can be used for diagnosis, satisfactory 3 points The image quality of PI/PC is basically equivalent to that of iDose4/ cardiac imaging. The image quality is defective, which does not affect the diagnosis, but is normal 2. The image quality of PI/PC is not lower than iDose4/ cardiac imaging, but the image quality is poor, which affects the diagnosis and is not satisfactory 1 points The image quality is lower than iDose4/ cardiac imaging after using PI/PC, the image quality is poor, cannot diagnose, unsatisfactory

  through study completion, an average of 2months

Secondary Outcomes (6)

• Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score

  through study completion, an average of 2months

• Imaging reconstruction diagnostic confidence using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score

  through study completion, an average of 2months

• Imaging reconstruction clarity using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score

  through study completion, an average of 2months

• Imaging reconstruction Noise level using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score

  through study completion, an average of 2months

• Imaging reconstruction Image texture using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score

  through study completion, an average of 2months

Study Arms (2)

Test Group

Using PI/PC reconstruct raw data

Other: CT Image reconstruction

Control Group

Using Idose4/Cardiac Image reconstruct raw data

Other: CT Image reconstruction

Interventions

CT Image reconstruction OTHER

Retrospectively collects CT Images and reconstruct using PI/PC and Idose4/Cardiac Images to assessment the performance of the two new software functions of Incisive CT. No direct intervention to patients. And ICF is exempted by EC.

Control Group; Test Group

Eligibility Criteria

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

Study Population

The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)

You may qualify if:

• The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)
• Original image data are collected in Incisive CT (version 4.5) and traceable;

You may not qualify if:

• \- The investigator deemed it inappropriate to include the original image data for this clinical trial

Sponsors & Collaborators

• Philips Healthcare (Suzhou) Co., Ltd.: lead
• The Second Hospital of Nanjing Medical University: collaborator

Study Officials

• Chao Du, Deputy Director

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Zhao

CONTACT

15000771460; Kevin.ZHAO_1@philips.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 25, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share