Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment

Sponsor

Fu Jen Catholic University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06147024

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm	Other: historical control Other: 3D printed lesion model	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Oct 5, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: historical control group conventional preoperative assessment	Other: historical control Received a conventional preoperative assessment
Experimental: 3D printed lesion model group using 3D printed lesion models for preoperative planning	Other: 3D printed lesion model Received 3D printed lesion models for preoperative planning

Arm

Intervention/Treatment

Active Comparator: historical control group

conventional preoperative assessment

Other: historical control

Received a conventional preoperative assessment

Experimental: 3D printed lesion model group

using 3D printed lesion models for preoperative planning

Other: 3D printed lesion model

Received 3D printed lesion models for preoperative planning

Outcome Measures

Primary Outcome Measures

surgical time [immediately after the surgical procedure]
the duration of the surgical procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City		Taiwan	24352

Sponsors and Collaborators

Fu Jen Catholic University

Investigators

Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University

ClinicalTrials.gov Identifier:

NCT06147024

Other Study ID Numbers:

FJUH112284

First Posted:

Nov 27, 2023

Last Update Posted:

Nov 27, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ke-Yun, Chao, Group leader of Respiratory Therapists, Fu Jen Catholic University

3D printing

pre-operative planning

thoracic aorta aneurysm

abdominal aorta aneurysm

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Study Results

No Results Posted as of Nov 27, 2023