CClinicalTrials.gg
Status unknownNCT04552054MR&3D LocalUpdated Sep 17, 2020

Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules

An interventional study of Mixed Reality+ 3D printing guided localization and Computerized Tomography guided localization in Video-assisted Thoracic Surgery, Lung Cancer and Pulmonary Nodule, Solitary, sponsored by Wen-zhao ZHONG. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by Wen-zhao ZHONG · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled May 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • pulmonary nodule
  • localization
  • three-dimensional printing
  • mixed reality
03

In context

Multiple Pulmonary Nodules

188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.

This study's planned enrollment of 136 is above the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

Wen-zhao ZHONG is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Active comparator
    CT guided localization

    Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization

    Device: Computerized Tomography guided 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

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.

06

What researchers measure

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.

    Time frame: During surgery

Secondary outcomes

  1. Time of localization

    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

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong 51000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04552054
Lead sponsor
Wen-zhao ZHONG
Collaborators
Guangdong Provincial People's Hospital
Responsible party
Wen-zhao ZHONG (Principal Investigator, Guangdong Provincial People's Hospital) — Sponsor-investigator
First posted
Sep 17, 2020
Start date
May 1, 2018
Primary completion
Oct 31, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Sep 17, 2020

Study contacts

Wen-Zhao Zhong, Ph.D
Contact
13609777314@163.com
+86-13609777314
Qiang Nie, Ph.D
Contact
18820792959@163.com
+86-18820792959
Wen-Zhao Zhong, Ph.D
principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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