Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

NCT ID: NCT06147024

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2024-10-31

Brief Summary

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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

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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

Conditions

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Aortic Aneurysm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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historical control group

conventional preoperative assessment

Group Type ACTIVE_COMPARATOR

historical control

Intervention Type OTHER

Received a conventional preoperative assessment

3D printed lesion model group

using 3D printed lesion models for preoperative planning

Group Type EXPERIMENTAL

3D printed lesion model

Intervention Type OTHER

Received 3D printed lesion models for preoperative planning

Interventions

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historical control

Received a conventional preoperative assessment

Intervention Type OTHER

3D printed lesion model

Received 3D printed lesion models for preoperative planning

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ke-Yun Chao, PhD

Role: CONTACT

+886905301879

Facility Contacts

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Ke-Yun Chao, PhD

Role: primary

+886-905-301-879

Other Identifiers

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FJUH112284

Identifier Type: -

Identifier Source: org_study_id

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