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Clinical Trials/NCT06147024
NCT06147024
Recruiting
N/A

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

Fu Jen Catholic University1 site in 1 country10 target enrollmentApril 8, 2024
ConditionsAortic Aneurysm

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Aneurysm
Sponsor
Fu Jen Catholic University
Enrollment
10
Locations
1
Primary Endpoint
surgical time
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
April 8, 2024
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

surgical time

Time Frame: immediately after the surgical procedure

the duration of the surgical procedure

Study Sites (1)

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