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临床试验/NCT05144620
NCT05144620已完成不适用

3D Printing for Pre-Surgical Planning

University of Colorado, Denver4 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
4
主要终点
Comparing 3D Models as a new diagnostic tool for pre-surgical training to reduce surgical time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • - Patients 65 and older

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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