To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic Anatomic Lobectomy (segmentectomy)
By comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter stapler and cartridge (the subject product) produced by Jiangsu Fengh Medical Co., Ltd. and the similar product (electric-endoscopic linear cutter stapler with articulating head) produced by Johnson \& Johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to prove that the subject product can be used for pulmonary tissue resection and anastomosis, and that the clinical trial meets the requirements of Good Clinical Practice for Medical Devices, Guidelines for Clinical Trial Design of Medical Devices and Guidelines for Technical Review of Endoscopic Stapler Registration, which can be used for product registration application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Jiangyin, Jiangsu, China
Number of Participants With Anastomosis Success
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure.
Time frame: During surgery
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