Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules
MR&3D Local
Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 17, 2020
May 1, 2020
2.5 years
August 28, 2020
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time of localization
During surgery
Study Arms (2)
CT guided localization
ACTIVE COMPARATORComputerized Tomography(CT)-guided percutaneous lung puncture staining marker localization
MR+3D guided localization
EXPERIMENTALMixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization
Interventions
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.
CT-guided percutaneous lung puncture staining marker localization.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wen-zhao ZHONGlead
- Guangdong Provincial People's Hospitalcollaborator
Study Sites (1)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 51000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Zhao Zhong, Ph.D
Guangdong Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 17, 2020
Study Start
May 1, 2018
Primary Completion
October 31, 2020
Study Completion
December 1, 2020
Last Updated
September 17, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share