Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

Suzhou Kerui Medical Technology Co., Ltd

Status: Not yet enrolling

Conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses

Treatments: Device: Disposable endoscopic linear cutter stapler

Study type: Observational

Funder types: Other

Identifiers

NCT06677008

CAK-PMCF

Details and patient eligibility

About

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.

Enrollment: 302 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age unlimited and gender unlimited;
• The surgery type shall be endoscopic surgery;
• The departments of surgical procedures: general and thoracic surgical procedures;
• Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.

Exclusion criteria

• Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
• Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
• Surgery record is incomplete, unable to extract main indicators related information.

Trial design

302 participants in 1 patient group

Disposable endoscopic linear cutter stapler

Treatment:

Device: Disposable endoscopic linear cutter stapler