NCT04552054

Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules

Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Wen-zhao ZHONG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the viability and accuracy of preoperative mixed reality technique combined with three-dimensional printing navigational template guided localizing pulmonary small nodules.

Detailed description

Pulmonary wedge resection is one of the most common types of operations performed by thoracic surgeons, especially given that more and more patients with ground glass nodules are being detected recently. One of the most significant current discussion concerning wedge resection is nodule localization. At present, a commonly used localization method is the CT-guided percutaneous lung puncture methylene blue staining marker localization, but this method has two main disadvantages: 1. the methylene blue dye is easy to spread, affecting the intraoperative judgment of nodule position by surgeon; 2. patients often suffer additional CT radiation. Mixed reality (MR) technique aims to enhance the simple self-visual effect and facilitate visualization of the surrounding environment in any situation. The three-dimensional model can be visualized by MR technique through MR glasses. Investigators project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest, and then use this as a guide for percutaneous lung puncture localization. At the same time, investigators design an three-dimensional printing navigational template based on the 3D reconstruction model and place it on the surface of the body to help to guide the localization. This study is designed to evaluates the viability and accuracy of preoperative mixed reality technique combined with 3D printing navigational template guided localizing pulmonary nodules.

Conditions

• Video-assisted Thoracic Surgery
• Lung Cancer
• Pulmonary Nodule, Solitary
• Pulmonary Nodule, Multiple

Interventions

Type	Name	Description
DEVICE	Mixed Reality+ 3D printing guided localization	Researchers project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest. Finally, researchers put the three-dimensional printing navigational template on the surface of the body to guide for percutaneous lung puncture localization.
DEVICE	Computerized Tomography guided localization	CT-guided percutaneous lung puncture staining marker localization.

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-10-31
• Completion: 2020-12-01
• First posted: 2020-09-17
• Last updated: 2020-09-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study