easyEndoTM Lite Staplers and Loading Units in Thoracic Surgery

January 6, 2026 updated by: Ezisurg Medical Co. Ltd.

A Retrospective Study to Evaluate the Safety and Effectiveness of easyEndoTM Lite Staplers and Loading Units

A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

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
    • Fujian
      • Fuzhou, Fujian, China, 350300
        • Fujian Medical University Union Hospital

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

The study population were patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.

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 Lite linear cutting stapler and loading units
Device: easyEndoTM Lite linear cutting stapler and loading units
using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stapling success rate
Time Frame: Perioperative/Periprocedural
No intrate-operative and post-operative air-leak
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Time Frame
Readmission rate
Time Frame: 30 days
30 days
Intraoperative blood loss
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Rate of convert to open surgery
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Hospitalization time
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Incidence of postoperative complications
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural

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)

January 3, 2021

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ESM-MDR-VIII 1006A

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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