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A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05651425
Collaborator
RenJi Hospital (Other), Shanxi Provincial People's Hospital (Other)
600
Enrollment
1
Location
4.3
Anticipated Duration (Months)
139.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. 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 efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning，which aims to avoid bias effictively and eliminate non-test interferences.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
    Anticipated Study Start Date :
    Dec 20, 2022
    Anticipated Primary Completion Date :
    Jan 20, 2023
    Anticipated Study Completion Date :
    Apr 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    surgeon-independent group

    the coiling diameter is predicted by experienced surgeon alone.
    surgeon-software-assistant group

    the coiling diameter is predicted by experienced surgeon with software assistant.

    Outcome Measures

    Primary Outcome Measures

    1. concordance rate [accessment time point : immediately after computational coiling diameter assessment finished.]

      the optimal coiling diameter used in surgery is considered as "gold standard". The concordance rate is defined as computational suitable coiling diameter in test group differs gold standard less than ±1mm. concordance rate=the number of concordance matched/totle enrolled number*100%

    Secondary Outcome Measures

    1. coincidence rate [accessment time point: immediately after computational coiling diameter assessment finished.]

      the optimal coiling diameter used in surgery is considered as "gold standard". The coincidence rate is defined as computational suitable coiling diameter in test group is less than gold standard. coincidence rate= the number meets coincidence requirement /totle enrolled *100%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. aged 18-80y, no gender limitation.

    2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.

    3. intracranial aneurysm diameter range from 3mm to 10mm.

    4. the shape of aneurysm is regular without daughter sac or more than 2 lobulations.

    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. significant proximal stenosis of parent artery;

    5. intracaverous internal carotid artery aneurysm;

    6. target aneurysm has been performed flow-diverter stents treatment.

    Exclusion criteria of images:

    1. none DICOM format;

    2. quality score less than 3 scores;

    3. metal artifacts existance.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital Beijing Beijing China

    Sponsors and Collaborators

    • Beijing Tiantan Hospital
    • RenJi Hospital
    • Shanxi Provincial People's Hospital

    Investigators

    • Principal Investigator: Shuo Wang, MD, Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wang Shuo, Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT05651425
    Other Study ID Numbers:
    • QX2022-011-02
    First Posted:
    Dec 15, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wang Shuo, Director of Department of Cerebrovascular Neurosurgery, Beijing Tiantan Hospital
    intracranial aneurysm
    intravascular coiling embolization
    Additional relevant MeSH terms:
    Intracranial Aneurysm
    Aneurysm

    Study Results

    No Results Posted as of Dec 15, 2022