Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers

Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.

NCT Number	NCT07028554
Lead Sponsor	Suzhou Care-Real Medical Technology Co., Ltd.
Conditions	the Transection of Tissues, the Resection of Tissues, the Creation of Anastomoses
Enrollment	300 participants
Start Date	2025-01-10
Primary Completion	2025-07-15 (estimated)
Study Completion	2025-07-15 (estimated)
Updated on ClinicalTrials.gov	2025-06-19