Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

Study Overview
=================
Brief Summary
-----------------
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)

Detailed Description
-----------------
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.

Official Title
-----------------
Clinical Trial on Effectiveness and Safety of Disposable Electric-Endoscopic Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Lung cancer surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18-70 (inclusive), with no gender limitation; The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment); Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent. Exclusion Criteria: Subjects have contraindications of video-assisted thoracoscopy; The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes; Subjects' platelet (PLT) <60x 10%/L or INR > 1.5; Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%; Cardiac ejection fraction ≤50%; Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots); The subject is a pregnant or lactating woman; The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial; Other conditions that the researcher judged inappropriate for inclusion. .

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Disposable Powered Articulating Endoscopic Linear Cutter Stapler<br>The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. | Device: Lung cancer surgery<br>* Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment<br>|
| Experimental: ECHELON Flex Powered Articulating Endoscopic Linear Cutters<br>ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. | Device: Lung cancer surgery<br>* Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomosis success rate | By comparing the anastomosis success rate of the two staplers, we can judge the safety and the effectiveness of the Fengh stapler. | During surgery |