Actively Recruiting
Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
Led by Suzhou Care-Real Medical Technology Co., Ltd. · Updated on 2025-06-19
300
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Surgery type must be open or endoscopic surgery
- Surgical procedures in general, gynecologic, urologic, or thoracic departments
- Use of investigational stapler devices listed in the study plan during surgery
You will not qualify if you...
- Patients with surgical contraindications to the product, such as use on large arteries, ischemic or necrotic tissue, or tissue thickness outside device range
- Use of similar stapler devices (staplers, reloads, cartridges) during surgery
- Incomplete operation records preventing extraction of main indicator information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cartridges of Disposable Endoscopic Linear Cutting Staplers
Ningbo, Zhejiang, Chile, 315101
Actively Recruiting
Research Team
K
Ke Zhou
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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