Today is 2021-01-18

Individualized 3D printing skull restoration based on artificial intelligence analysis and transmission data
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注册号:

Registration number:

ChiCTR2000038813 

最近更新日期:

Date of Last Refreshed on:

2020-12-27 

注册时间:

Date of Registration:

2020-10-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于人工智能分析传输数据实现个体化3D打印颅骨修复 

Public title:

Individualized 3D printing skull restoration based on artificial intelligence analysis and transmission data 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于人工智能分析传输数据实现个体化3D打印颅骨修复 

Scientific title:

Individualized 3D printing skull restoration based on artificial intelligence analysis and transmission data 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

N/A 

申请注册联系人:

张驰 

研究负责人:

冯金周 

Applicant:

Zhang Chi 

Study leader:

Feng Jinzhou 

申请注册联系人电话:

Applicant telephone:

+86 15184336062 

研究负责人电话:

Study leader's telephone:

+86 13688360199 

申请注册联系人传真 :

Applicant Fax:

NA 

研究负责人传真:

Study leader's fax:

N/A 

申请注册联系人电子邮件:

Applicant E-mail:

280649307@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

feng720930@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

N/A 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

N/A 

申请注册联系人通讯地址:

成都市青羊区一环路西二段32号 

研究负责人通讯地址:

成都市青羊区一环路西二段32号 

Applicant address:

32 West Second Section of First Ring Road, Qingyang District, Chengdu, Sichuan, China 

Study leader's address:

32 West Second Section of First Ring Road, Qingyang District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

N/A 

研究负责人邮政编码:

Study leader's postcode:

N/A 

申请人所在单位:

四川省医学科学院·四川省人民医院 

Applicant's institution:

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

伦审(研)2020年第419号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川省医学科学院·四川省人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-03 

伦理委员会联系人:

雍正平、王海江 

Contact Name of the ethic committee:

Zhengping Yong, Haijiang Wang 

伦理委员会联系地址:

成都市青羊区一环路西二段32号 

Contact Address of the ethic committee:

32 West Second Section of First Ring Road, Qingyang District, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

N/A 

研究实施负责(组长)单位:

四川省医学科学院·四川省人民医院 

Primary sponsor:

Sichuan Academy of Medical Sciences · Sichuan Provincial people's Hospital 

研究实施负责(组长)单位地址:

成都市青羊区一环路西二段32号 

Primary sponsor's address:

32 West Second Section of First Ring Road, Qingyang District, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省医学科学院·四川省人民医院

具体地址:

青羊区一环路西二段32号

Institution
hospital:

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

Address:

32 West Second Section of First Ring Road, Qingyang District

经费或物资来源:

四川省科学技术厅、四川华曙图灵增材制造技术有限责任公司、江油市人民医院 

Source(s) of funding:

Sichuan provincial Department of Science and Technology, Sichuan Hushu turing additive Manufacturing Technology Co.LCT、Jiangyou People's Hospital 

研究疾病:

颅脑损伤 

Target disease:

Skull defect 

研究疾病代码:

N/A 

Target disease code:

N/A 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究旨在优化3D打印产品从临床数据采集到生产交付的整体流程,采用人工智能辅助三维建模系统,使用国产PEEK或金属钛网等材料,通过3D打印技术,实现快速、精准、智能制备个性化颅骨(PEEK或钛网)修复植入器械,缩短制备周期,降低制造成本,减轻患者与医保压力,实现精准治疗。 

Objectives of Study:

The purpose of this study is to optimize the overall process from clinical data collection to production and delivery of 3D printing products. By using artificial intelligence assisted 3D modeling system, using domestic peek materials and 3D printing technology, we can quickly, accurately and intelligently prepare peek personalized skull repair implant device, shorten the preparation cycle, reduce the manufacturing cost, reduce the pressure of patients and medical insurance, and achieve accurate treatment. 

药物成份或治疗方案详述:

N/A 

Description for medicine or protocol of treatment in detail:

N/A 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1)14 岁~74 岁; (2)颅骨缺损面积超过 3*3CM, 且颅内压正常; (3)病人愿意接受定制的个性化颅骨修复成品进行颅骨修补。 

Inclusion criteria

1. Patients aged from 14 to 74 years old; 2. Patients with skull defect area more than 3 * 3cm and normal intracranial pressure; 3. Patients are willing to accept customized personalized skull repair products for skull repair. 

排除标准:

(1)颅骨修复手术区有感染未控制; (2)长期卧床的患者, 身体状态差, 无法耐受手术修复者。 

Exclusion criteria:

1. There were patients with uncontrollable infection in cranioplasty operation area; 2. Patients who are bedridden for a long time are in poor physical condition and can not tolerate surgical repair. 

研究实施时间:

Study execute time:

From2020-01-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-10-10To 2021-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

基础治疗

干预措施代码:

Intervention:

basis treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省医学科学院·四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

头部薄层CT

指标类型:

主要指标 

Outcome:

Thin-section CT of the head

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅骨缺损面积

指标类型:

主要指标 

Outcome:

Skull defect area

Type:

Primary indicator 

测量时间点:

手术前

测量方法:

CT软件测量

Measure time point of outcome:

Before surgery

Measure method:

CT software measurement

指标中文名:

颅骨缺损修复程度

指标类型:

主要指标 

Outcome:

Repair degree of skull defect

Type:

Primary indicator 

测量时间点:

术后3天内

测量方法:

术前后三维模型对比

Measure time point of outcome:

Within 3 days after operation

Measure method:

Comparison of three-dimensional models before and after operation

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

渗出液

组织:

修补颅骨周围

Sample Name:

percolate

Tissue:

around the skull repaired

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

未使用

Randomization Procedure (please state who generates the random number sequence and by what method):

Not use

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

Not stated 请阅读网页注册指南中关于“原始数据共享”的内容。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Not stated

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-04
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