A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement

March 27, 2023 updated by: Wang Shuo, Beijing Tiantan Hospital
the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chinese

Description

Inclusion Criteria:

  1. aged 18-75y, no gender limitation.
  2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
  3. Intracranial aneurysm was not treated.

Inclusion criteria of images:

  1. the number of detector rows of Computed Tomography(CT) is more than 16 rows.
  2. slice thickness ≤ 0.625mm, whole-brain image is considered.
  3. Both plain scan sequences and enhancer sequence are required.

Exclusion Criteria:

  1. combined with cerebral hemorrhage;
  2. combined with cerevascular malformation or cerebral occupying lesion;
  3. fusiform aneurysm or dissection aneurysm;
  4. intracaverous internal carotid artery aneurysm;

Exclusion criteria of images:

  1. none DICOM format;
  2. quality score less than 3 scores;
  3. metal artifacts existance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracranial Aneurysms
Other: Observational study
Observational study
Normal Vessels
Other: Observational study
Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intracranial aneurysm size
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Intracranial aneurysm volume
Time Frame: 10 years
10 years
Intracranial aneurysm height
Time Frame: 10 years
10 years
Intracranial aneurysm neck diameter
Time Frame: 10 years
10 years
Parent artery diameter
Time Frame: 10 years
10 years
Intracranial aneurysm width
Time Frame: 10 years
10 years
Aspect ratio
Time Frame: 10 years
10 years
Size ratio
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Beijing Friendship Hospital
RenJi Hospital
Beijing Chao Yang Hospital
Guangzhou Red Cross Hospital
Shanxi Provincial People's Hospital
Wuxi No. 2 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

March 25, 2023

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QX2022-011-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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