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

Suzhou Kerui Medical Technology Co., Ltd

Status: Enrolling

Conditions: the Creation of Anastomoses; the Resection of Tissues; the Transection of Tissues

Treatments: Device: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered

Study type: Observational

Funder types: Other

Identifiers

NCT07028554

WEKD-QS-PMCF

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years old, gender unlimited;
2. The surgery type shall be open or endoscopic surgery;
3. The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
4. Investigational devices listed in this PMCF plan must be used during surgical procedures.

Exclusion criteria

1. Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
2. Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
3. The operation record is incomplete, and the information related to the main indicators cannot be extracted.

Trial design

300 participants in 1 patient group

Cartridges of Disposable Endoscopic Linear Cutting Staplers

Description:

Investigational devices are 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.

Treatment:

Device: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered