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OpenTrials
Completed

NCT Number: NCT05804474

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Inclusion criteria

of images:

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

Exclusion criteria

  • combined with cerebral hemorrhage;
  • combined with cerevascular malformation or cerebral occupying lesion;
  • fusiform aneurysm or dissection aneurysm;
  • intracaverous internal carotid artery aneurysm;

Exclusion criteria

of images:

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

Treatment and study plan

observational study

Other

Observational study

Primary outcomes

  1. Intracranial aneurysm size

    Time frame: 10 years

Secondary outcomes

  1. Intracranial aneurysm volume

    Time frame: 10 years

  2. Intracranial aneurysm height

    Time frame: 10 years

  3. Intracranial aneurysm neck diameter

    Time frame: 10 years

  4. Parent artery diameter

    Time frame: 10 years

  5. Intracranial aneurysm width

    Time frame: 10 years

  6. Aspect ratio

    Time frame: 10 years

  7. Size ratio

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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