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

Not yet recruiting

• Conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses

• Registration Number: NCT06677008
• Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Study Start: 2024-11-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 302

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.

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 September 2024.	The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.

Secondary Outcome Measures

Name	Time	Method
Operation time	The investigation sites will be collected from January 2023 to September 2024.	Confirmed by surgical records and anesthesia sheets.
Amount of intraoperative blood loss	the investigation sites will be collected from January 2023 to September 2024.	Confirmed by surgical records/nursing notes.
Intraoperative conversion (caused by the stapler and/or cartridge)	the investigation sites will be collected from January 2023 to September 2024.	Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description.
Length of hospitalization	the investigation sites will be collected from January 2023 to September 2024.	Records were collected for the patient's date of surgery and date of discharge .; Length of hospitalization(days) = date of discharge - date of surgery
All-cause re-hospitalization rate (within 6 months)	From the date of surgery to six months after the surgery	Re-hospitalization data of patients within 6 months after surgery were collected.; Postoperative all-cause re-hospitalization rate = number of all-cause re-hospitalization cases/total cases ×100%

Trial Locations

Locations (1)

Disposable endoscopic linear cutter stapler; 🇨🇳 Wujin District, Changzhou, China