Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules (MR&3D Local)
Primary Purpose
Video-assisted Thoracic Surgery, Lung Cancer, Pulmonary Nodule, Solitary
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mixed Reality+ 3D printing guided localization
Computerized Tomography guided localization
Sponsored by
About this trial
This is an interventional treatment trial for Video-assisted Thoracic Surgery focused on measuring pulmonary nodule, localization, three-dimensional printing, mixed reality
Eligibility Criteria
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
Sites / Locations
- Guangdong Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CT guided localization
MR+3D guided localization
Arm Description
Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization
Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization
Outcomes
Primary Outcome Measures
Puncture success rate of localization
The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.
Secondary Outcome Measures
Time of localization
To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.
Full Information
NCT ID
NCT04552054
First Posted
August 28, 2020
Last Updated
September 10, 2020
Sponsor
Wen-zhao ZHONG
Collaborators
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04552054
Brief Title
Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules
Acronym
MR&3D Local
Official Title
Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen-zhao ZHONG
Collaborators
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video-assisted Thoracic Surgery, Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
Keywords
pulmonary nodule, localization, three-dimensional printing, mixed reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT guided localization
Arm Type
Active Comparator
Arm Description
Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization
Arm Title
MR+3D guided localization
Arm Type
Experimental
Arm Description
Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization
Intervention Type
Device
Intervention Name(s)
Mixed Reality+ 3D printing guided localization
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Computerized Tomography guided localization
Intervention Description
CT-guided percutaneous lung puncture staining marker localization.
Primary Outcome Measure Information:
Title
Puncture success rate of localization
Description
The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Time of localization
Description
To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Zhao Zhong, Ph.D
Phone
+86-13609777314
Email
13609777314@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Nie, Ph.D
Phone
+86-18820792959
Email
18820792959@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Zhao Zhong, Ph.D
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Zhao Zhong, Ph.D
Phone
+86-13609777314
Email
13609777314@163.com
First Name & Middle Initial & Last Name & Degree
Qiang Nie, Ph.D
Phone
+86-18820792959
Email
18820792959@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules
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