Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler; Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

• Registration Number: NCT05329402
• Lead Sponsor: Fengh Medical Co., Ltd.

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.

Study Timeline

• Study Start: 2018-10-22
• Primary Completion: 2019-09-11
• Study Completion: 2020-03-05
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Results First Submitted: 2023-02-16
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-22
• Last Update Submitted: 2023-11-22
• Results First Posted: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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. .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Disposable Powered Articulating Endoscopic Linear Cutter Stapler
ECHELON Flex Powered Articulating Endoscopic Linear Cutters	ECHELON Flex Powered Articulating Endoscopic Linear Cutters	ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler; 🇨🇳 Jiangyin, Jiangsu, China