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Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

NCT04788082 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-09

No results posted yet for this study

Summary

Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.

Conditions

  • Double Outlet Right Ventricle
  • Transposition of the Great Arteries
  • Truncus Arteriosus
  • Congenitally Corrected Transposition of the Great Arteries

Interventions

DIAGNOSTIC_TEST

3D Printed Heart Model

Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.

Sponsors & Collaborators

Principal Investigators

  • Laura Olivieri, MD · Children's National Research Institute

  • Stephen Pophal, MD · Phoenix Children's Hospital

  • Yoav Dori, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788082 on ClinicalTrials.gov