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

Launched by SUZHOU KERUI MEDICAL TECHNOLOGY CO., LTD · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medical device called a disposable endoscopic linear cutter stapler, which is used during surgeries to help cut and connect tissues in the body. The study aims to evaluate how safe and effective this stapler is for procedures that involve removing or joining soft tissues, such as during general or thoracic surgeries. Researchers will analyze past clinical data to understand how well this device performs.

Anyone can participate in this trial as long as they are having endoscopic surgery, which is a type of minimally invasive procedure where doctors use a small camera and instruments. However, patients who have certain conditions that might make using the stapler unsafe, or those who are having surgery with other similar devices, will not be eligible. While the study is not yet recruiting participants, it will provide valuable information on how this stapler can be used safely and effectively in surgical procedures.

Gender

ALL

Eligibility criteria

• 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.