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

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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasm
• Intervention / Treatment: Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler; Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

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 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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Jiangyin, Jiangsu, China, 214437
      • Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler; Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
Active Comparator: ECHELON Flex Powered Articulating Endoscopic Linear Cutters	Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters; Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fengh Medical Co., Ltd.
• Collaborators: Shanghai Tong Ren Hospital; The Central Hospital of Lishui City; Affiliated Hospital of Jiangsu University; People's Hospital of Quzhou; First People's Hospital of Yangzhou
• Investigators: Principal Investigator: Qing Ni, First People's Hospital of Yangzhou

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 20256031708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants can only see the results of CT, blood routine, coagulation function, fasting blood glucose, fecal occult blood test, cardiac ultrasound, pulmonary function and gastrointestinal angiography, and the other results are not shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No