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

Fengh Medical

Status

Completed

Conditions

Gastrointestinal Neoplasm

Treatments

Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05320029

20256031708

Details and patient eligibility

About

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

Full description

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.

Enrollment

164 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.