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

NCT07028554 | Recruiting

• 1 other identifier: WEKD-QS-PMCF
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

the Transection of Tissues; the Resection of Tissues; the Creation of Anastomoses

Outcome Measures

Primary Outcomes (1)

• Anastomosis success rate

  According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.

  The investigation sites will be collected from January 2023 to June 2024.

Secondary Outcomes (3)

• 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.

Other Outcomes (4)

• Surgical time

  The investigation sites will be collected from January 2023 to June 2024.

• Intraoperative bleeding

  The investigation sites will be collected from January 2023 to June 2024.

• Intraoperative conversion (due to device reasons)

  The investigation sites will be collected from January 2023 to June 2024.

Study Arms (1)

Cartridges of Disposable Endoscopic Linear Cutting Staplers

Investigational devices are 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.

Device: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered

Interventions

Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered DEVICE

Investigational devices encompassing all models of the Cartridges for Disposable Endoscopic Linear Cutting Staplers, as well as Staplers utilized in conjunction with the Cartridges specified in the Study Plan (Plan number: WEKD-QS-PMCF).

Cartridges of Disposable Endoscopic Linear Cutting Staplers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cartridges of Disposable Endoscopic Linear Cutting Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments are applied in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. They must be used in combination with Disposable Powered Endoscopic Linear Cutting Staplers or Disposable Endoscopic Linear Cutting Staplers manufactured by the Company.

You may qualify if:

• Age≥18 years old, gender unlimited;
• The surgery type shall be open or endoscopic surgery;
• The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
• Investigational devices listed in this PMCF plan must be used during surgical procedures.

You may not qualify if:

• 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;
• Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
• The operation record is incomplete, and the information related to the main indicators cannot be extracted.

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead

Study Sites (1)

Cartridges of Disposable Endoscopic Linear Cutting Staplers

Ningbo, Zhejiang, 315101, Chile

RECRUITING

Central Study Contacts

Ke Zhou

CONTACT

+86 18118447767; ke.zhou@care-real.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: January 10, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)