跳至主要内容
临床试验/NCT06147024
NCT06147024招募中不适用

Utilizing 3D Printed Personalized Aortic Lesion Models to Assist Surgeons in Preoperative Assessment and Planning of Aortic Aneurysm Surgery

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
surgical time

研究概览

简要总结

Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.

详细描述

Background: Previous systematic reviews have indicated that approximately 82% of surgeries using 3D printed lesion models for preoperative planning have shown better surgical outcomes, and about half of the surgeries have demonstrated reduced operative time. In recent years, there have been numerous studies focusing on the application of 3D printing technology in aortic aneurysms. This study aims to employ 3D printing technology to fabricate personalized aortic blood vessel models with lesions.

Study Design: A single-centre, pilot study.

Methods: This study is a single-center, prospective clinical trial. The study plans to enroll 10 participants in the experimental group, and collect data from another 10 participants as the historical control group. The historical control group data will be matched-paired based on gender, age, and surgical type in sequential order.

Effect: We anticipate that through the use of 3D printed lesion models, we can reduce surgical time, decrease surgery-related complications, and enhance the smoothness of surgical team preparation for the procedure. Additionally, this approach can provide patients with a better understanding of their own condition and the upcoming surgical intervention.

Key words: 3D printing; pre-operative planning; thoracic aorta aneurysm; abdominal aorta aneurysm

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with thoracic or abdominal aortic aneurysm
  • •Signed surgical consent
  • •Non-emergent surgery
  • •Had 2D CT imaging within the last 6 months

排除标准

  • •Refusal to use lesion images for model creation
  • •Refusal to participate in the study

研究组 & 干预措施

historical control group

Active Comparator

conventional preoperative assessment

干预措施: historical control (Other)

3D printed lesion model group

Experimental

using 3D printed lesion models for preoperative planning

干预措施: 3D printed lesion model (Other)

结局指标

主要结局

surgical time

时间窗: immediately after the surgical procedure

the duration of the surgical procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (1)

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