Cartridges of Disposable Endoscopic Linear Cutting Staplers
Ningbo, Zhejiang, 315101, Chile
Location status: Recruiting
Recruiting
NCT Number: NCT07028554
Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered
DeviceInvestigational 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 outcomes
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Anastomosis success rate
Time frame: The investigation sites will be collected from January 2023 to June 2024.
According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.
Secondary outcomes
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Anastomotic bleeding rate
Time frame: The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.
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Anastomotic leakage rate
Time frame: The incidence of leakage during day of operation and 6 months after operation was recorded.
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Anastomotic stenosis rate
Time frame: The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.
Other outcomes
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Surgical time
Time frame: The investigation sites will be collected from January 2023 to June 2024.
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Intraoperative bleeding
Time frame: The investigation sites will be collected from January 2023 to June 2024.
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Intraoperative conversion (due to device reasons)
Time frame: The investigation sites will be collected from January 2023 to June 2024.
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Length of hospitalization
Time frame: The investigation sites will be collected from January 2023 to June 2024.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Suzhou Care-Real Medical Technology Co., Ltd.
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jun 19, 2025
- Registry last updated
- Jun 19, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.