NCT05144620: 3D

3D Printing for Pre-Surgical Planning

Completed NA Last updated 5 February 2024

What this trial tests

NA trial testing 3D Mapping in Surgical Patients in 38 participants. Completed in 19 June 2023.

Timeline

30 December 2021

Primary endpoint
7 December 2022

19 June 2023

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	38
Start date	30 December 2021
Primary completion	7 December 2022
Estimated completion	19 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• 3D Mapping

Conditions studied

• Surgical Patients — all drugs for Surgical Patients →

Sponsor

University of Colorado, Denver

Who can join

Adults 1 Month to 65, any sex, with Surgical Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation.

Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hybrid modeling techniques for 3D printed deep inferior epigastric perforator flap models.
   Jacobson NM, Carerra E, Treat A, McDonnell M, et al · · 2023 · cited 3× · PMID 37700101 · DOI 10.1186/s41205-023-00181-z