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easyEndoTM Powered in Thoracic Surgery

E

Ezisurg Medical Co. Ltd.

Status

Completed

Conditions

Lung Cancer (NSCLC)

Treatments

Device: easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges

Study type

Interventional

Funder types

Other

Identifiers

NCT07353489
JN-Elite-01

Details and patient eligibility

About

The goal of this retrospective, single-arm is to evaluate the safety and performance of the easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges in thoracic surgery. The main question it aims to answer is the safety and performance of the staplers

Enrollment

61 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who underwent thoracic surgery (including lobectomy, segmentectomy, wedge resection, etc.) using easyEndo™ Powered Single-Use Powered Endoscopic Staplers and Cartridges at our hospital.
  • Surgery date was on or after January 1, 2024.
  • Patients with complete medical records (including demographic data, surgical details, perioperative management, and follow-up information).
  • Patients who completed a 1-year postoperative follow-up, with available and valid follow-up data

Exclusion criteria

  • Patients who used other brands or types of endoscopic staplers instead of easyEndo™ Powered Single-Use Powered Endoscopic Staplers and Cartridges during surgery.
  • Surgery date was before January 1, 2024.
  • Patients with incomplete medical records or missing key information (e.g., unclear surgical procedures, unrecorded stapler use details, lost to follow-up before 1 year).
  • Patients with severe underlying diseases that may affect postoperative outcomes or follow-up, such as end-stage heart, liver, or kidney disease, severe coagulation disorders, or uncontrolled malignant tumors (other than the primary disease requiring thoracic surgery).
  • Patients with allergies to the materials of easyEndo™ staplers or cartridges, or who experienced adverse reactions related to stapler material allergies intraoperatively or postoperatively.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges
Experimental group
Treatment:
Device: easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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