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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Experimental | Disposable Powered Articulating Endoscopic Linear Cutter Stapler |
|
| ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Active Comparator | ECHELON Flex Powered Articulating Endoscopic Linear Cutters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Device | Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment |
| 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 The device is withdrawn after successful triggering.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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Qing Ni | First People's Hospital of Yangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Jiangyin | Jiangsu | 214437 | China |
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment |
| FG001 | Echelon Flex POWERED Articulating Endoscopic Linear Cutters |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2019 |
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Patients randomized to the trial group and the control group will not cross use the product
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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
| ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Device | Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment |
|
Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment |
| BG001 | Echelon Flex POWERED Articulating Endoscopic Linear Cutters | Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | During surgery |
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30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment | 0 | 80 | 11 | 80 | 65 | 80 |
| EG001 | Echelon Flex POWERED Articulating Endoscopic Linear Cutters | Gastrointestinal tumor surgery: Only the brand of electric cutting stapler used by different groups was different, and the rest were treated according to routine treatment | 1 | 80 | 9 | 80 | 68 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| gastric retention | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Eating obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Esophagojejunostomotic fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection of incisional wound | Infections and infestations | Systematic Assessment |
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| The anastomosis is narrow | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pelvic infection | Infections and infestations | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Subdiaphragmatic abscess | Infections and infestations | Systematic Assessment |
| ||
| Hemorrhage of digestive tract | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholecystolithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoproteinemia | Metabolism and nutrition disorders | Systematic Assessment |
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| fever | General disorders | Systematic Assessment |
| ||
| incision pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiao Liu | Fengh Medical Co., Ltd. | 13815132106 | jiao.liu@fulbrightmed.com |
| Nov 23, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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