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NCT Number: NCT06555276

Post-market Clinical Follow-up of Disposable Endoscope Linear Cutting Staplers and Components

This is a multi-center and retrospective cohort study to evaluate the efficacy and safety of disposable linear cutting staplers and components in soft tissue resection, transection and anastomosis.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

About this study

The disposable endoscopic linear cutting staplers and components developed and produced by Jiangsu Channel Medical Device Co., Ltd. can be used in open or endoscopic surgery of lung, bronchial tissue, stomach and intestine resection, transection and anastomosis. They have been registered in China for many years and have been widely used, and have been certified by the European Union in 2021. The number is CIM.2021.106.14629. This study intends to conduct a multi-center retrospective cohort study in China, collect clinical application data of Chinese patients, conduct statistical analysis on the clinical application data, confirm whether the expected effectiveness and safety are achieved, and further extrapolate to the EU population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gender unlimited, age unlimited ② open or endoscopic surgery ③ resection, transection and anastomosis of lung, bronchial tissue, stomach and intestines.
  • use the study device during surgery

Exclusion criteria

  • patients with contraindications to the product, such as severe mucosal edema, operation of the hemostatic site that cannot be observed, or off-label use of the liver and spleen;
  • combined with other similar products (staplers) for surgical site excision, transsection and anastomosis; ③ surgical records are incomplete, and information related to major indicators cannot be extracted; ④ other situations that the researcher considers inappropriate for inclusion in the study.

Treatment and study plan

Disposable endoscope linear cutting stapler and components

Device

to use the study device for excision, transection and anastomosis of lung, bronchial tissue, stomach and intestine in open or endoscopic surgery.

Primary outcomes

  1. anastomosis success rate

    Time frame: within six months after surgery

    According to surgical records and hospitalization records, the condition of no reoperation in situ was defined as successful anastomosis. Anastomosis success rate=cases of successful anastomosis/total cases of surgery ×100%

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Zhang

CONTACT

13500206389

zhengliang Tu

CONTACT

[email protected]

13600513557

Sponsors and collaborators

Lead sponsor

Suzhou Care-Real Medical Technology Co., Ltd.

Other

Collaborators

  • Jiangsu Channel Medical Device Co., Ltd.

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

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.

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