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NCT Number: NCT06147024

Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, 24352, Taiwan

Location status: Recruiting

Location contact

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886-905-301-879

Ke-Yun Chao, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

historical control

Other

Received a conventional preoperative assessment

3D printed lesion model

Other

Received 3D printed lesion models for preoperative planning

Primary outcomes

  1. surgical time

    Time frame: immediately after the surgical procedure

    the duration of the surgical procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886905301879

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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