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

NCT05329402 | Completed Results

• 1 other identifier: 20256031708-BC1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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)

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 The device is withdrawn after successful triggering.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

Study Arms (2)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

EXPERIMENTAL

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

ACTIVE COMPARATOR

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Interventions

Disposable Powered Articulating Endoscopic Linear Cutter Stapler DEVICE

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

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

ECHELON Flex Powered Articulating Endoscopic Linear Cutters DEVICE

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

ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fengh Medical Co., Ltd.: lead

Study Sites (1)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler

Jiangyin, Jiangsu, 214437, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Jiao Liu
• Organization: Fengh Medical Co., Ltd.

jiao.liu@fulbrightmed.com

13815132106

Study Officials

• Yusheng Shu

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 15, 2022
• Study Start: October 22, 2018
• Primary Completion: September 11, 2019
• Study Completion: March 5, 2020
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)