NCT06555276

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 195 (estimated)
• Sponsor: Suzhou Care-Real Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Disease

Interventions

Type	Name	Description
DEVICE	Disposable endoscope linear cutting stapler and components	to use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: China