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

Suzhou Kerui Medical Technology Co., Ltd1 site in 1 country302 target enrollmentNovember 15, 2024

ConditionsThe Expeditious Transection/resection of Tissues and Creation of Anastomoses

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses
Sponsor: Suzhou Kerui Medical Technology Co., Ltd
Enrollment: 302
Locations: 1
Primary Endpoint: Anastomosis success rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.

Registry

clinicaltrials.gov

Start Date

November 15, 2024

End Date

February 28, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Suzhou Kerui Medical Technology Co., Ltd

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Anastomosis success rate

Time Frame: the investigation sites will be collected from January 2023 to September 2024.

The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.

Secondary Outcomes

Operation time(The investigation sites will be collected from January 2023 to September 2024.)
Amount of intraoperative blood loss(the investigation sites will be collected from January 2023 to September 2024.)
Intraoperative conversion (caused by the stapler and/or cartridge)(the investigation sites will be collected from January 2023 to September 2024.)
Length of hospitalization(the investigation sites will be collected from January 2023 to September 2024.)
All-cause re-hospitalization rate (within 6 months)(From the date of surgery to six months after the surgery)