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Not yet recruiting NCT06677008

Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

— Observational The Expeditious Transection/resection of Tissues and Creation of Anastomoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disposable endoscopic linear cutter stapler.
Who it may be relevant to
Registry conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.

Interventions

  • Device Disposable endoscopic linear cutter stapler
    Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)

Primary outcome measures

  • Anastomosis success rate [Time frame: the investigation sites will be collected from January 2023 to September 2024.]
Secondary outcome measures (5)
  • Operation time [Time frame: The investigation sites will be collected from January 2023 to September 2024.]
  • Amount of intraoperative blood loss [Time frame: the investigation sites will be collected from January 2023 to September 2024.]
  • Intraoperative conversion (caused by the stapler and/or cartridge) [Time frame: the investigation sites will be collected from January 2023 to September 2024.]
  • Length of hospitalization [Time frame: the investigation sites will be collected from January 2023 to September 2024.]
  • All-cause re-hospitalization rate (within 6 months) [Time frame: From the date of surgery to six months after the surgery]

Eligibility criteria

Inclusion criteria

  • Age unlimited and gender unlimited;
  • The surgery type shall be endoscopic surgery;
  • The departments of surgical procedures: general and thoracic surgical procedures;
  • Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.

Exclusion criteria

  • Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
  • Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
  • Surgery record is incomplete, unable to extract main indicators related information.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Disposable endoscopic linear cutter stapler — Wujin District

Identifiers

NCT: NCT06677008 · CAK-PMCF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗