Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis

Study Overview
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Brief Summary
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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 Gastrointestinal Tissue Cutting and Anastomosis

Detailed Description
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In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson & Johnson.

Official Title
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Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis

Conditions
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Gastrointestinal Neoplasm

Intervention / Treatment
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* Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler
* Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subjects are 18   75 years old, regardless of gender: Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis: The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent. Exclusion Criteria: The subject plans to perform emergency gastrointestinal surgery: Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g / L): Subject BMI 228kg / m2; Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5; Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%; Subject's cardiac ejection fraction ≤ 50%; Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values Upper limit 3 times and above: subjects with fasting blood glucose value > 10.0mmol/l before operation: The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue Subjects participated in clinical trials of other drugs or devices within 3 months before the trial; Other conditions that the researchers judged not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients randomized to the trial group and the control group will not cross use the product
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disposable Powered Articulating Endoscopic Linear Cutter Stapler<br>Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler<br>* Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment<br>|
| Active Comparator: ECHELON Flex Powered Articulating Endoscopic Linear Cutters<br>ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters<br>* Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure. | During surgery |