Incisive CT Clinica Trial Protocol

NCT ID: NCT05020262

Last Updated: 2021-08-25

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

UNKNOWN

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-01-31

Brief Summary

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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

Detailed Description

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Conditions

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CT Images

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Test Group

Using PI/PC reconstruct raw data

CT Image reconstruction

Intervention Type 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

Using Idose4/Cardiac Image reconstruct raw data

CT Image reconstruction

Intervention Type 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.

Interventions

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CT Image reconstruction

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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;
* Time range for inclusion of original image data: from the start of the clinical trial to the completion of collection in compliance with this protocol;

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Philips Healthcare (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chao Du, Deputy Director

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Central Contacts

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Kevin Zhao

Role: CONTACT

15000771460

Other Identifiers

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PD_CT_Incisive CT_2021_11264

Identifier Type: -

Identifier Source: org_study_id

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