Lung Cancer
Conditions
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 Thoracoscopic Anatomic Lobectomy (segmentectomy)
Detailed description
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.
Interventions
Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment
Sponsors
Fengh Medical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18-70 (inclusive), with no gender limitation; 2. The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment); 3. Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.
Exclusion criteria
1. Subjects have contraindications of video-assisted thoracoscopy; 2. The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes; 3. Subjects' platelet (PLT) \<60x 10%/L or INR \> 1.5; 4. Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%; 5. Cardiac ejection fraction ≤50%; 6. Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots); 7. The subject is a pregnant or lactating woman; 8. The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial; 9. Other conditions that the researcher judged inappropriate for inclusion. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anastomosis Success | During surgery | 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. |
Countries
China
Participant flow
Recruitment details
30 days
Participants by arm
| Arm | Count |
|---|---|
| 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 | 79 |
| 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 | 83 |
| Total | 162 |
Baseline characteristics
| Characteristic | Disposable Powered Articulating Endoscopic Linear Cutter Stapler | ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Total |
|---|---|---|---|
| Age, Continuous | 54.95 years STANDARD_DEVIATION 9.77 | 55.33 years STANDARD_DEVIATION 8.94 | 55.14 years STANDARD_DEVIATION 9.33 |
| BMI | 23.88 kg/m^2 STANDARD_DEVIATION 3.34 | 24.06 kg/m^2 STANDARD_DEVIATION 3.24 | 23.97 kg/m^2 STANDARD_DEVIATION 3.28 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 79 participants | 83 participants | 162 participants |
| Sex: Female, Male Female | 40 Participants | 51 Participants | 91 Participants |
| Sex: Female, Male Male | 39 Participants | 32 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 83 |
| other Total, other adverse events | 44 / 79 | 54 / 83 |
| serious Total, serious adverse events | 10 / 79 | 8 / 83 |
Outcome results
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.
Time frame: During surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Disposable Powered Articulating Endoscopic Linear Cutter Stapler | Number of Participants With Anastomosis Success | 79 Participants |
| ECHELON Flex Powered Articulating Endoscopic Linear Cutters | Number of Participants With Anastomosis Success | 83 Participants |
p-value: 0.972795% CI: [-0.0285, 0.0273]Wald