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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 Thoracoscopic Anatomic Lobectomy (segmentectomy)
By comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter stapler and cartridge (the subject product) produced by Jiangsu Fengh Medical Co., Ltd. and the similar product (electric-endoscopic linear cutter stapler with articulating head) produced by Johnson & Johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to prove that the subject product can be used for pulmonary tissue resection and anastomosis, and that the clinical trial meets the requirements of Good Clinical Practice for Medical Devices, Guidelines for Clinical Trial Design of Medical Devices and Guidelines for Technical Review of Endoscopic Stapler Registration, which can be used for product registration application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Experimental | Disposable Powered Articulating Endoscopic Linear Cutter Stapler |
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| 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 The device is withdrawn after successful triggering.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. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure. | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusheng Shu | Northern Jiangsu People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Jiangyin | Jiangsu | 214437 | China |
Only the results of CT, routine blood test, coagulation function, fasting blood glucose, occult blood test of stool, cardiac ultrasound, lung function and digestive tract angiography were available to the participants, and other results were not shared
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30 days
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| ID | Title | Description |
|---|---|---|
| FG000 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. |
| 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 | Mar 25, 2019 |
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| ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Device | Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment |
|
| FG001 | ECHELON Flex Powered Articulating Endoscopic Linear Cutters | ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. Lung cancer 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 | ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Lung cancer 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 |
|
| 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/m^2 |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and 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 | The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. | 0 | 79 | 10 | 79 | 44 | 79 |
| EG001 | ECHELON Flex Powered Articulating Endoscopic Linear Cutters | ECHELON Flex Powered Articulating Endoscopic Linear Cutters has application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. | 0 | 83 | 8 | 83 | 54 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Right pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary artery bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Aerodermectasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thoracic wall lung hernia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Lung leak gas | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| left chest pain | Cardiac disorders | Systematic Assessment |
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| Acute cerebral infarction | Nervous system disorders | Systematic Assessment |
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| Left lower lung with residual pulmonary atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Glaucoma | Eye disorders | Systematic Assessment |
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| Chylopleura | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Abnormal liver function | Hepatobiliary disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Systematic Assessment |
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| emesis | Gastrointestinal disorders | Systematic Assessment |
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| aypnia | Nervous system disorders | Systematic Assessment |
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| others | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiao Liu | Fengh Medical Co., Ltd. | 13815132106 | jiao.liu@fulbrightmed.com |
| Nov 22, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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