Status:
COMPLETED
Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Lead Sponsor:
Fengh Medical Co., Ltd.
Conditions:
Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 A...
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 pr...
Eligibility Criteria
Inclusion
- Subjects aged 18-70 (inclusive), with no gender limitation;
- The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment);
- Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.
Exclusion
- Subjects have contraindications of video-assisted thoracoscopy;
- The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes;
- Subjects' platelet (PLT) \<60x 10%/L or INR \> 1.5;
- Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%;
- Cardiac ejection fraction ≤50%;
- 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);
- The subject is a pregnant or lactating woman;
- The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial;
- Other conditions that the researcher judged inappropriate for inclusion. .
Key Trial Info
Start Date :
October 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05329402
Start Date
October 22 2018
End Date
March 5 2020
Last Update
May 2 2024
Active Locations (1)
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1
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Jiangyin, Jiangsu, China, 214437