Menu
Recruiting NCT07028554

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

— Observational the Transection of Tissues the Resection of Tissues the Creation of Anastomoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered.
Who it may be relevant to
Registry conditions: the Transection of Tissues, the Resection of Tissues, the Creation of Anastomoses. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered
    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).

Primary outcome measures

  • Anastomosis success rate [Time frame: The investigation sites will be collected from January 2023 to June 2024.]
Secondary outcome measures (3)
  • Anastomotic bleeding rate [Time frame: The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.]
  • Anastomotic leakage rate [Time frame: The incidence of leakage during day of operation and 6 months after operation was recorded.]
  • Anastomotic stenosis rate [Time frame: The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Chile · 1 center
  • Cartridges of Disposable Endoscopic Linear Cutting Staplers — Ningbo

Identifiers

NCT: NCT07028554 · WEKD-QS-PMCF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗