Video-assisted Thoracic SurgeryMR&3D LocalNCT04552054
Mixed Reality Technique Combined With 3D Printing Navigational Template for Localizing Pulmonary Nodules
A study testing Mixed Reality+ 3D printing guided localization and Computerized Tomography guided localization in people with Video-assisted Thoracic Surgery and Lung Cancer, run by Wen-zhao ZHONG at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video-assisted Thoracic Surgery, Lung Cancer, Pulmonary Nodule, Solitary
- What is being tested?
- Mixed Reality+ 3D printing guided localization and Computerized Tomography guided localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 51000
Wen-Zhao Zhong, Ph.D, +86-13609777314, 13609777314@163.com
Qiang Nie, Ph.D, +86-18820792959, 18820792959@163.com
About this study
Official title: 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.
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.
- Conditions
- Video-assisted Thoracic Surgery, Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- Being tested
- Mixed Reality+ 3D printing guided localization, Computerized Tomography guided localization
- Keywords
- pulmonary nodule, localization, three-dimensional printing, mixed reality
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Reality+ 3D printing guided localizationDevice
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 localizationDevice
CT-guided percutaneous lung puncture staining marker localization.
| Study group | Role | What they receive |
|---|---|---|
| CT guided localization | Active comparator | Computerized Tomography(CT)-guided percutaneous lung puncture staining marker localization Receives: Device: Computerized Tomography guided localization |
| MR+3D guided localization | Experimental | Mixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization Receives: Device: Mixed Reality+ 3D printing guided localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture success rate of localization
The deviations of less than 2 cm between the lesion and the injected site was defined as successful localization.
Measured: 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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 May 2018
- Primary completion31 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
- Investigators
- Wen-Zhao Zhong, Ph.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552054
- Sponsor's protocol ID
- 46783912
- Acronym
- MR&3D Local
- Status last verified
- May 2020
- First submitted
- 28 Aug 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Mixed Reality Technique Combined With Three-Dimensional Printing Navigational Template Guided Localizing Pulmonary Small Nodules : a Prospective, Unicenter, Randomized Study.
- ClinicalTrials.gov ID
- NCT04552054
- Acronym / sponsor ID
- MR&3D Local / 46783912
- Conditions
- Video-assisted Thoracic Surgery, Lung Cancer, Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- Keywords
- pulmonary nodule, localization, three-dimensional printing, mixed reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Wen-zhao ZHONGUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT guided localization | Active comparator | Device: Computerized Tomography guided localizationComputerized Tomography(CT)-guided percutaneous lung puncture staining marker localization |
| MR+3D guided localization | Experimental | Device: Mixed Reality+ 3D printing guided localizationMixed reality(MR)+3D printing-guided percutaneous lung puncture staining marker localization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Reality+ 3D printing guided localizationResearchers 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. | Device | MR+3D guided localization |
| Computerized Tomography guided localizationCT-guided percutaneous lung puncture staining marker localization. | Device | CT guided localization |
Primary outcome
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.
1 secondary outcome
Time of localization
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Video-assisted Thoracic Surgery
RecruitingObservational study
Sensory Anesthesia Achieved Through Different Paravertebral Block Approaches for Post-Op Pain Management After VATS Lung Resection
Thoracic Surgery, Video-assisted
Not yet recruiting
Post-operative Medium Chain Triglyceride Diet May Reduce Hospital Stay Following Lung Resection
Thoracic Neoplasms
Recruiting
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS Ngoerah
Pain, Postoperative Pain
Recruiting
Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
Postoperative Pain, Thoracic Surgery
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Zhao Zhong, Ph.D principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality+ 3D printing guided localization and Computerized Tomography guided localization in people with Video-assisted Thoracic Surgery and Lung Cancer, run by Wen-zhao ZHONG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Zhao Zhong, Ph.D (+86-13609777314, 13609777314@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture success rate of localization (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.