Pulmonary NoduleNCT06335563
Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules
A study testing AR glasses-assisted pulmonary nodule puncture localization and CT-guided pulmonary nodule puncture localization in people with Pulmonary Nodule, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule
- What is being tested?
- AR glasses-assisted pulmonary nodule puncture localization and CT-guided pulmonary nodule puncture localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2024to 1 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80, no gender limit;
- Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
- Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
- Physical condition score ECOG 0-2 points;
- If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
- Patients voluntarily participate and sign informed consent.
Who cannot join
- The lesion is located in front of the scapula, and the needle path is blocked;
- The distance between the center of the lesion and the top of the diaphragm is < 3 cm;
- The lesion is adjacent to the hilus or large blood vessels;
- Pleural adhesions caused by a history of thoracotomy or pleural infection;
- The patient voluntarily withdraws midway.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shenghao Huang, huangshplus5@163.com
About this study
Official title: Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial
This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.
Read the detailed description
This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.
- Conditions
- Pulmonary Nodule
- Being tested
- AR glasses-assisted pulmonary nodule puncture localization, CT-guided pulmonary nodule puncture localization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR glasses-assisted pulmonary nodule puncture localizationProcedure or surgery
Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.
CT-guided pulmonary nodule puncture localizationProcedure or surgery
Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| AR glasses-assisted pulmonary nodule puncture localization | Experimental | Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. Receives: Procedure: AR glasses-assisted pulmonary nodule puncture localization |
| CT-guided pulmonary nodule puncture localization | Active comparator | Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. Receives: Procedure: CT-guided pulmonary nodule puncture localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of puncture localization of pulmonary nodules
Quantified as the shortest distance from the actual position of the puncture needle tip to the originally planned puncture point
Measured: Intraoperative
Secondary outcomes (4)
Success rate of puncture localization of pulmonary nodules
The puncture is defined as successful when the distance between the actual localizing point of the puncture needle tip and the center of the localized nodule does not exceed 20 mm.
Measured: Intraoperative
Adjust the number of needle punctures
Number of needle insertion attempts required for successful localizing
Measured: Intraoperative
Operating time
The time span from the patient's first CT scan to the last CT scan, in minutes
Measured: Intraoperative
Radiation dose
The length product value of the radiation dose recorded by the CT scanner, measured in mGy * cm
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start14 Mar 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies 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
- Model description
- AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deping Zhao, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Deping Zhao, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335563
- Sponsor's protocol ID
- STAR009
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Wang L, Wang X, Sun W, Sun F, Guo Z, Zhao M, Chen T, Wen J, Shen X, Shi X, Zhang L, Wan Z, Chen Q, Deng J, She Y, Xie D, Zhao D, Chen C. Real-time AR navigation with dynamic tracking for millimeter-level pulmonary nodule localization: A randomized clinical trial. Cell Rep Med. 2026 Aug 18;7(8):102942. doi: 10.1016/j.xcrm.2026.102942. Epub 2026 Jul 28.
PubMed 42520806
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT06335563
- Acronym / sponsor ID
- STAR009
- Conditions
- Pulmonary Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (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 aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.
Detailed description
This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary nodule puncture localizing group
| Arm | Type | Receives |
|---|---|---|
| AR glasses-assisted pulmonary nodule puncture localization | Experimental | Procedure: AR glasses-assisted pulmonary nodule puncture localizationCombined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. |
| CT-guided pulmonary nodule puncture localization | Active comparator | Procedure: CT-guided pulmonary nodule puncture localizationPositioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80, no gender limit;
- Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
- Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
- Physical condition score ECOG 0-2 points;
- If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
Key exclusion criteria (5 listed)
- The lesion is located in front of the scapula, and the needle path is blocked;
- The distance between the center of the lesion and the top of the diaphragm is < 3 cm;
- The lesion is adjacent to the hilus or large blood vessels;
- Pleural adhesions caused by a history of thoracotomy or pleural infection;
- The patient voluntarily withdraws midway.
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 |
|---|---|---|
| AR glasses-assisted pulmonary nodule puncture localizationCombined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. | Procedure or surgery | AR glasses-assisted pulmonary nodule puncture localization |
| CT-guided pulmonary nodule puncture localizationPositioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn. | Procedure or surgery | CT-guided pulmonary nodule puncture localization |
Primary outcome
Accuracy of puncture localization of pulmonary nodules
Time frame: Intraoperative
Quantified as the shortest distance from the actual position of the puncture needle tip to the originally planned puncture point
4 secondary outcomes
Success rate of puncture localization of pulmonary nodules
Time frame: Intraoperative
Adjust the number of needle punctures
Time frame: Intraoperative
Operating time
Time frame: Intraoperative
Radiation dose
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 42520806Huang S, Wang L, Wang X, Sun W, Sun F, Guo Z, Zhao M, Chen T, Wen J, Shen X, Shi X, Zhang L, Wan Z, Chen Q, Deng J, She Y, Xie D, Zhao D, Chen C. Real-time AR navigation with dynamic tracking for millimeter-level pulmonary nodule localization: A randomized clinical trial. Cell Rep Med. 2026 Aug 18;7(8):102942. doi: 10.1016/j.xcrm.2026.102942. Epub 2026 Jul 28.
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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.
Deping Zhao, MD, PhD principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR glasses-assisted pulmonary nodule puncture localization and CT-guided pulmonary nodule puncture localization in people with Pulmonary Nodule, run by Shanghai Pulmonary Hospital, Shanghai, China 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 6 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 12 Apr 2024. 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 Yunlang She, MD (+86 17749739242, sylxan3344@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of puncture localization of pulmonary nodules (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335563, which also lists 1 linked publication.
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 12 Apr 2024.