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

Gastrointestinal Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320029
• Other study ID #: 20256031708
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: November 2023
• Source: Fengh Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Gastrointestinal Tissue Cutting and Anastomosis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 20, 2022
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. The subjects are 18 ~ 75 years old, regardless of gender:

2. Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:

3. 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:

1. The subject plans to perform emergency gastrointestinal surgery:

2. Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g / L):

3. Subject BMI 228kg / m2;

4. Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;

5. Subject forced expiratory volume per second (FEV1) / expected value = 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;

6. Subject's cardiac ejection fraction = 50%;

7. 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:

8. 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

9. Subjects participated in clinical trials of other drugs or devices within 3 months before the trial;

10. Other conditions that the researchers judged not suitable for inclusion.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms

Intervention

Device:
• Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
• ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Locations

Country	Name	City	State
China	Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Jiangyin	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Fengh Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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