Recruiting

Disposable Endoscopic Linear Cutting Staplers Post-Market Follow-Up

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Study Aim

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.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2025
See protocol details

Summary

Principal SponsorSuzhou Kerui Medical Technology Co., Ltd
Study ContactKe Zhou
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePost-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
NCT07028554
Principal SponsorSuzhou Kerui Medical Technology Co., Ltd
Study ContactKe Zhou
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

4 inclusion criteria required to participate
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.

3 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Recruiting

Cartridges of Disposable Endoscopic Linear Cutting Staplers

Ningbo, ChileOpen Cartridges of Disposable Endoscopic Linear Cutting Staplers in Google Maps
Recruiting
One Study Center