Status:
COMPLETED
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Lead Sponsor:
Fengh Medical Co., Ltd.
Conditions:
Gastrointestinal Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
NA
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 A...
Detailed 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 Pow...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05320029
Start Date
August 30 2018
End Date
January 20 2022
Last Update
December 14 2023
Active Locations (1)
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1
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Jiangyin, Jiangsu, China, 214437