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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04552054
Other study ID # 46783912
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date December 1, 2020

Study information

Verified date May 2020
Source Guangdong Provincial People's Hospital
Contact Wen-Zhao Zhong, Ph.D
Phone +86-13609777314
Email 13609777314@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 136
Est. completion date December 1, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
Computerized Tomography guided localization
CT-guided percutaneous lung puncture staining marker localization.

Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Wen-zhao ZHONG Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Puncture success rate of localization The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization. During surgery
Secondary Time of localization To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively. During surgery
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