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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2020-03-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Powered Surgical Stapler in VATS Lung Resection Procedures in China

NCT02338583

Non-small Cell Lung Cancer

COMPLETED

Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea

NCT02196675

Non-small Cell Lung Cancer (NSCLC)

COMPLETED

A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

NCT03056300

Non-Small Cell Lung Cancer

COMPLETED NA

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

NCT01003522

Non-small Cell Lung Cancer

UNKNOWN PHASE3

Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy

NCT05245630

Lung Cancer Lung Diseases Adenocarcinoma of Lung

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Group Type EXPERIMENTAL

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Intervention Type DEVICE

Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Group Type ACTIVE_COMPARATOR

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Intervention Type DEVICE

Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment

Intervention Type DEVICE

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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. .

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No