Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components

Suzhou Kerui Medical Technology Co., Ltd

Status: Not yet enrolling

Conditions: Gastric Disease

Treatments: Device: Disposable endoscope linear cutting stapler and components

Study type: Observational

Funder types: Other

Identifiers

NCT06555276

CN-ED-CTP

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 195 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.