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

Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

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)

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler; Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Jiangyin, Jiangsu, China, 214437
      • Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler; Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
Active Comparator: ECHELON Flex Powered Articulating Endoscopic Linear Cutters	Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters; Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fengh Medical Co., Ltd.
• Collaborators: Shenzhen Second People's Hospital; Northern Jiangsu Province People's Hospital; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University; Ningbo No.2 Hospital; Second Affiliated Hospital of Shantou University Medical College
• Investigators: Principal Investigator: Yusheng Shu, Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20256031708-BC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No