RuijinhospitalRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
NCT Number: NCT04211051
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
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects should meet all of the following criteria
Exclusion criteria
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 .
Time frame: Immediately after resection
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
Time frame: Duration of procedure
Collect total procedure time for lung localization and surgical resection.
Time frame: One month
Procedure-related complications will be recorded.
Ruijin Hospital
Other
Safety and Feasibility of a Novel Pulmonary Surgery Marker System in the Intraoperative Localization of Small Pulmonary Nodules
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