Safety and Feasibility of Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules

Study Overview
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Brief Summary
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As the detection of small pulmonary nodules continuously grows, the intraoperative localization of small pulmonary nodules is in great demand. The intraoperative localization nowadays is usually done under local anesthesia before surgery. There is a certain rate of failure and complication. The result of our early animal experiments show that the pulmonary surgery marker system can deliver the intraoperative localization safely and precisely under anesthesia, and the average distance between the localization and the simulated lesion is less than 5mm during surgery. Therefore, the safety and feasibility of the system require further evaluation in patients

Detailed Description
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This is a prospective, single-center clinical trial initiated by the investigator. LungBrella marker can be accurately implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery. The study is expected to enroll 10 patients. Finally, the effectiveness and safety of the method will be evaluated. This method not only can complete pulmonary nodule localization in the operating room without occupying the resources of radiology department, but also can let patients receive pulmonary nodule location after anesthesia. Thereby the risks during transportation are avoided and the suffering of patients is reduced.

Official Title
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Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Device: LungBrella marker implantation and VATS partial lobe resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should meet all of the following criteria diagnosis of pulmonary nodule, single nodule operation to be performed and nodule to be located by the decision of chief surgeon. commit to follow the research procedures and cooperate with the implementation of the whole process research 1 / 3 of pulmonary nodules are located in the periphery of the lung signed informed consent with date Exclusion Criteria: the target lesion is close to the hilar or large blood vessels subjects with FEV1 less than 1.2 in lung function subjects with cardiac function III and cardiac function IV (NYHA, New York) subjects with uncontrollable acute pleura infection patients with previous history of thoracic surgery (thoracotomy), plural infection, and plural thickening and adhesion on the affected side Other factors that investigators disagree enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>LungBrella marker implanted into a predetermined position in the lung assisted by JediVision software and successfully marked the pulmonary nodules which needs to undergo Video-assisted thoracoscopic surgery | Device: LungBrella marker implantation and VATS partial lobe resection<br>* The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positioning success rate | When the distance between the LungBrella marker and the Pulmonary nodule is less than 10mm, the marker position is successful. The success rate is the proportion of successful cases to all operation cases | Immediately after resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Collect total procedure time for lung localization and surgical resection. | Duration of procedure | 
| Complications | Procedure-related complications will be recorded. | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung neoplasm, localization of lung nodules, ground glass opacity