Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules (MR&3D Local)

September 10, 2020 updated by: Wen-zhao ZHONG

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 51000
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CT guided localization
Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization
Device: Computerized Tomography guided localization
CT-guided percutaneous lung puncture staining marker localization.
Experimental: MR+3D guided localization
Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Puncture success rate of localization
Time Frame: During surgery
The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of localization
Time Frame: During surgery
To evaluate the time of the localization in each groups. The investigators record the start and end time of localization respectively.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wen-zhao ZHONG

Collaborators

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Wen-Zhao Zhong, Ph.D, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46783912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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