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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses
• Intervention / Treatment: Device: Disposable endoscopic linear cutter stapler

• Study Type: Observational
• Enrollment (Estimated): 302

Contacts and Locations

• Study Contact: Name: Ke Zhou; Phone Number: +86 18118447767; Email: ke.zhou@care-real.com

Study Locations

• China
  • Changzhou
    • Wujin District, Changzhou, China
      • Disposable endoscopic linear cutter stapler
      • Contact: Xiaohong Xu; Phone Number: +86 13915015530; Email: xuxiaohong@czakyl.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Disposable endoscopic linear cutter stapler	Device: Disposable endoscopic linear cutter stapler; Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomosis success rate	The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.	the investigation sites will be collected from January 2023 to September 2024.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc.	From the date of surgery to six months after the surgery
Device deficiencies	Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.	From the date of surgery to six months after the surgery
Serious adverse events	Incidence of serious adverse events = Number of serious adverse events/number of enrolled cases ×100%	From the date of surgery to six months after the surgery

Collaborators and Investigators

• Sponsor: Suzhou Kerui Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CAK-PMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No