Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers

Launched by SUZHOU KERUI MEDICAL TECHNOLOGY CO., LTD · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and performance of special surgical tools called disposable endoscopic linear cutting staplers. These tools are used by surgeons to cut and join tissues during various types of surgeries, such as general, gynecologic (women’s health), urologic (urinary system), and thoracic (chest) procedures. The study aims to make sure these devices work well and are safe to use by collecting information from patients who have had surgeries with these staplers in countries like Italy, Brazil, and Chile.

Adults aged 18 and older who are having either open surgery or minimally invasive surgery using these specific staplers may be eligible to join. To participate, the devices must be used during the surgery, and the surgery must be done in one of the mentioned departments. People who have conditions that make using these staplers unsafe, or who have had other similar devices used during their surgery, would not be eligible. Participants can expect their surgical outcomes and any side effects to be closely monitored to help doctors better understand how safe and effective these staplers are over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age≥18 years old, gender unlimited;
• • 2. The surgery type shall be open or endoscopic surgery;
• • 3. The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
• • 4. Investigational devices listed in this PMCF plan must be used during surgical procedures.
• Exclusion Criteria:
• • 1. Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
• • 2. Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
• • 3. The operation record is incomplete, and the information related to the main indicators cannot be extracted.