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Trial Title:
Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules
NCT ID:
NCT06335563
Condition:
Pulmonary Nodule
Conditions: Official terms:
Multiple Pulmonary Nodules
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
AR glasses-assisted puncture localizing group versus CT-guided conventional pulmonary
nodule puncture localizing group
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
no masking
Intervention:
Intervention type:
Procedure
Intervention name:
AR glasses-assisted pulmonary nodule puncture localization
Description:
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sheath is withdrawn.
Arm group label:
AR glasses-assisted pulmonary nodule puncture localization
Intervention type:
Procedure
Intervention name:
CT-guided pulmonary nodule puncture localization
Description:
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.
Arm group label:
CT-guided pulmonary nodule puncture localization
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-80, no gender limit;
2. Chest CT shows that the nodule involves the outer third of the lung and can be
removed by wedge resection;
3. Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
4. Physical condition score ECOG 0-2 points;
5. If you plan to undergo percutaneous puncture and localization of small pulmonary
nodules, the puncture needle path will be determined by the attending physician;
6. Patients voluntarily participate and sign informed consent.
Exclusion Criteria:
1. The lesion is located in front of the scapula, and the needle path is blocked;
2. The distance between the center of the lesion and the top of the diaphragm is < 3
cm;
3. The lesion is adjacent to the hilus or large blood vessels;
4. Pleural adhesions caused by a history of thoracotomy or pleural infection;
5. The patient voluntarily withdraws midway.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Shenghao Huang
Email:
huangshplus5@163.com
Start date:
March 14, 2024
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06335563
