Status:
NOT_YET_RECRUITING
Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components
Lead Sponsor:
Suzhou Kerui Medical Technology Co., Ltd
Collaborating Sponsors:
Jiangsu Channel Medical Device Co., Ltd.
Conditions:
Gastric Disease
Eligibility:
All Genders
Brief Summary
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.
Detailed Description
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,...
Eligibility Criteria
Inclusion
- gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
- use the study device during surgery
Exclusion
- patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;
- combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.
Key Trial Info
Start Date :
August 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT06555276
Start Date
August 20 2024
End Date
December 31 2024
Last Update
August 15 2024
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China