Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147024
• Other study ID #: FJUH112284
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Fu Jen Catholic University
• Contact: Ke-Yun Chao, PhD
• Phone: +886905301879
• Email: C00152[@]mail.fjuh.fju.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Other:
• historical control
Received a conventional preoperative assessment
• 3D printed lesion model
Received 3D printed lesion models for preoperative planning

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical time	the duration of the surgical procedure	immediately after the surgical procedure