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This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.
The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.
Age
All ages
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
August 20, 2024
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
August 15, 2024
195
ESTIMATED participants
Disposable endoscope linear cutting stapler and components
DEVICE
Lead Sponsor
Suzhou Kerui Medical Technology Co., Ltd
Collaborators
NCT06958250
NCT06273319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04479423