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Clinical Trials/NCT05144620
NCT05144620CompletedNot Applicable

3D Printing for Pre-Surgical Planning

University of Colorado, Denver4 sites in 1 country38 target enrollmentStarted: December 30, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
4
Primary Endpoint
Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time

Study Overview

Brief Summary

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.

Detailed Description

The tangible outcome of this research will be measured in a comparative study. The investigators will compare the 3D printed models, resulting from the development of this iterative process of generating models from ultra-high resolution medical images and review by all parties, to radiological images and pathological data. The study team will employ non-biased methods to quantify the results of this comparative study. There will be no randomization and all subjects will receive the same treatments and all outcomes are data focused. Models will not be used for patient treatment and will be used only as to aid preparation and will not be used as a therapeutic device. For this reason, the study team will not prospectively consent subjects.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Month to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • - Patients seen at UCHealth/CHCO and NOC sites between 6/1/2021 - 6/1/2026
  • Pregnant women and their fetuses

Exclusion Criteria

  • - Patients 65 and older

Outcomes

Primary Outcomes

Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time

Time Frame: 3 years

Focus on using pre-operative imaging for producing 3D models for 3 specific presurgical evaluations 1) Adult Clear Cell Renal Mass with a focus on partial nephrectomies. 2) Pediatric Cardiothoracic Surgery 3) Pediatric Neurosurgical primary brain tumor resection involving eloquent areas of the brain (eg speech center, auditory center, visual center, motor cortex, and sensory cortex). 4) Plastic Surgery and Craniomaxillofacial disciplines with a focus on DIEP Flap reconstructions and Alveolar Bone Graft procedures. Change in surgical time based on using a 3D model per-operatively

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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