Back to resultsClinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Primary Purpose
Gastrointestinal Neoplasm
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gastrointestinal tumor surgery
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasm
Eligibility Criteria
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.
Sites / Locations
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
Arm Description
Outcomes
Primary Outcome Measures
Anastomosis success rate
By comparing the anastomotic success rate of the two staplers, we can judge the safety and effectiveness of the wind and stapler.
Secondary Outcome Measures
Full Information
NCT ID
NCT05320029
First Posted
March 31, 2022
Last Updated
July 25, 2022
Sponsor
Fengh Medical Co., Ltd.
Collaborators
First People's Hospital of Yangzhou, Affiliated Hospital of Jiangsu University, People's Hospital of Quzhou, The Central Hospital of Lishui City, Shanghai Tong Ren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05320029
Brief Title
Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Official Title
Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
January 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fengh Medical Co., Ltd.
Collaborators
First People's Hospital of Yangzhou, Affiliated Hospital of Jiangsu University, People's Hospital of Quzhou, The Central Hospital of Lishui City, Shanghai Tong Ren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to the trial group and the control group will not cross use the product
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A test method in which subjects are not told whether they are a trial device or a control device in order to control intentional or unintentional bias in the course of a clinical trial and in the interpretation of results
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Arm Type
Active Comparator
Arm Title
Echelon Flex POWERED Articulating Endoscopic Linear Cutters
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Gastrointestinal tumor surgery
Intervention Description
Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment
Primary Outcome Measure Information:
Title
Anastomosis success rate
Description
By comparing the anastomotic success rate of the two staplers, we can judge the safety and effectiveness of the wind and stapler.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
214437
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Learn more about this trial
Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
We'll reach out to this number within 24 hrs