easyEndoTM Powered in Thoracic Surgery

January 19, 2026 updated by: Ezisurg Medical Co. Ltd.

Evaluation of the Safety and Efficacy of Single Use Powered Endoscopic Staplers and Cartridges in Thoracic Surgery: A Retrospective Clinical Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jining, Shandong, China, 272000
        • Affiliated Hospital of Jining Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges
Device: easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges
Using easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges transection, resection, and/or creation of anastomoses in thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stapling success rate
Time Frame: Perioperative/Periprocedural
no leakage intra-operation and post-operation
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative blood loss volume
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Blood transfusion requirement
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Conversion to open thoracotomy
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Length of hospital stay
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Postoperative drainage duration
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
total drainage volume
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Reoperation requirement
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
The incidence of complications
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ezisurg Medical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JN-Elite-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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