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

Recruiting

• Conditions: the Transection of Tissues; the Resection of Tissues; the Creation of Anastomoses

• Registration Number: NCT07028554
• Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd

Brief Summary

Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures.

In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-10
• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anastomosis success rate	The investigation sites will be collected from January 2023 to June 2024.	According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.

Secondary Outcome Measures

Name	Time	Method
Anastomotic bleeding rate	The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.
Anastomotic leakage rate	The incidence of leakage during day of operation and 6 months after operation was recorded.
Anastomotic stenosis rate	The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.

Trial Locations

Locations (1)

Cartridges of Disposable Endoscopic Linear Cutting Staplers; 🇨🇱 Ningbo, Zhejiang, Chile

Cartridges of Disposable Endoscopic Linear Cutting Staplers

🇨🇱Ningbo, Zhejiang, Chile

Mi Zhao

Contact

+8618317178013

zhaomi@nbverykind.com