Disposable Endoscopic Linear Cutting Staplers Post-Market Follow-Up
This study observes how disposable endoscopic linear cutting staplers perform after market release, with a focus on their impact on anastomosis success rates in patients.
Data Collection
Collected from past medical records and data - RetrospectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 10, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding and confirming the safety and effectiveness of certain medical devices used in surgery, specifically the cartridges of disposable endoscopic linear cutting staplers. These devices are used in various types of surgeries, such as those involving the abdomen, chest, and reproductive organs, and are already being used in many countries including Italy, Brazil, and Chile. The goal is to ensure these devices continue to perform well and safely over time. By closely monitoring any side effects, both known and new, the study aims to make sure that the benefits of using these devices outweigh any risks, thus improving surgical outcomes and patient safety. Participants in the study will need to undergo surgeries where these stapling devices are used, and detailed clinical data will be collected both during and after the procedures to assess their success. The main focus is on the success rate of anastomoses, which are connections made between two structures, typically during surgery. A successful outcome is defined as no need for further surgery in the same area. By reviewing surgical and medical records, researchers aim to gather comprehensive evidence on the device's performance and any potential risks, ensuring its continued safe use in medical practices.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cartridges of Disposable Endoscopic Linear Cutting Staplers
Ningbo, ChileOpen Cartridges of Disposable Endoscopic Linear Cutting Staplers in Google Maps