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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04552054
Acronym
MR&3D Local
Enrollment
136
Registered
2020-09-17
Start date
2018-05-01
Completion date
2020-12-01
Last updated
2020-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

pulmonary nodule, localization, three-dimensional printing, mixed reality

Brief 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.

Interventions

DEVICEMixed 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.

DEVICEComputerized Tomography guided localization

CT-guided percutaneous lung puncture staining marker localization.

Sponsors

Guangdong Provincial People's Hospital
CollaboratorOTHER
Wen-zhao ZHONG
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* a maximum target lung nodule (one or more) diameter ≤20 mm * a target nodule CTR \<0·25 or a minimum distance from the outer edge of the nodule to the nearest pleural surface \>10 mm if the target nodule CTR was \>0·25. * Plan to perform VATS lung wedge resection

Exclusion criteria

* Inability to comply with research protocols or research procedures * Any unstable systemic disease (including active infections, uncontrolled high blood pressure, unstable angina, angina pectoris that has started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] Level II ), cardiac infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic disease * Active bleeding; Inability to withstand lying flat; Inability to cooperate through breathing during puncture * Pregnant or lactating women * Other circumstances that the investigator believes are not suitable for enrollment

Design outcomes

Primary

MeasureTime frameDescription
Puncture success rate of localizationDuring surgeryThe deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.

Secondary

MeasureTime frameDescription
Time of localizationDuring surgeryTo evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.

Countries

China

Contacts

Primary ContactWen-Zhao Zhong, Ph.D
13609777314@163.com+86-13609777314
Backup ContactQiang Nie, Ph.D
18820792959@163.com+86-18820792959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026