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

Not yet recruiting

• Conditions: Gastric Disease

• Registration Number: NCT06555276
• Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd

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, 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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Study Start: 2024-08-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anastomosis success rate	within six months after surgery	According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China