Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants

NCT ID: NCT05603949

Last Updated: 2023-02-13

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

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-03

Study Completion Date

2023-07-15

Brief Summary

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This project aims to develop an effective deep learning system to generate numerical implant geometry based on 3D defective skull models from CT scans. This technique is beneficial for the design of implants to repair skull defects above the Frankfort horizontal plane.

Detailed Description

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Designing a personalized implant to restore the protective and aesthetic functions of the patient's skull is challenging. The skull defects may be caused by trauma, congenital malformation, infection, and iatrogenic treatments such as decompressive craniectomy, plastic surgery, and tumor resection. The project aims to develop a deep learning system with 3D shape reconstruction capabilities. The system will meet the requirement of designing high-resolution 3D implant numerical models efficiently.

A collection of skull images were used for training the deep learning system. Defective models in the datasets were created by numerically masking areas of intact 3D skull models. The final implant design should be verified by neurosurgeons using 3D printed models.

Conditions

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Skull Defect

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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experimental group

3D deep learning neural network system

Intervention Type DEVICE

With the consent of the patient, we will assist in the production of images of 3D defect blocks for free (3D deep learning neural network system (3D DNN) system process planning), complete the repair and reconstruction under the clinical routine surgery, and track the repair results after surgery. meet medical needs.

Interventions

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3D deep learning neural network system

With the consent of the patient, we will assist in the production of images of 3D defect blocks for free (3D deep learning neural network system (3D DNN) system process planning), complete the repair and reconstruction under the clinical routine surgery, and track the repair results after surgery. meet medical needs.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Scheduled for cranioplasty
2. Informed consent

Exclusion Criteria

(1)No informed consent
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yau-Zen Chang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Linkou Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yau-zen chang

Role: CONTACT

(03)211-8800 ext. 5341

Facility Contacts

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Yau-zen Chang, PhD

Role: primary

Other Identifiers

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202201082B0

Identifier Type: -

Identifier Source: org_study_id

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