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| Name | Class |
|---|---|
| Shanghai Futuo Zhida Medical Technology Co., Ltd | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungBrella marker implantation and VATS partial lobe resection | Device | 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 . |
| 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 |
| 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. |
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Inclusion Criteria:
Subjects should meet all of the following criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hecheng Li, MD&PHD | Ruijin hospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Hecheng Li, MD&PHD | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37691871 | Derived | Li C, Ji A, Jian Z, Zheng Y, Feng X, Guo W, Lerut T, Lin J, Li H. Augmented reality navigation-guided intraoperative pulmonary nodule localization: a pilot study. Transl Lung Cancer Res. 2023 Aug 30;12(8):1728-1737. doi: 10.21037/tlcr-23-201. Epub 2023 Aug 4. | |
| 35004246 | Derived | Li C, Zheng Y, Yuan Y, Li H. Augmented reality navigation-guided pulmonary nodule localization in a canine model. Transl Lung Cancer Res. 2021 Nov;10(11):4152-4160. doi: 10.21037/tlcr-21-618. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| One month |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |