Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation

January 12, 2026 updated by: Ezisurg Medical Co. Ltd.

The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications.

Participants will undergoing thoracic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • Zhejiang
      • Jinhua, Zhejiang, China, 321000
        • Jinhua municipal central 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Older than 18 years old, male or female;
  2. Subjects are scheduled to undergo open or thoracoscopic puimonary surgery with any surgicalprocedure;
  3. The surgery is performed using the easyEndotm Lite Linear Cuting Stapler for Single Use andLoading Unites for Single Use for tissue cutting and suturing.

Exclusion Criteria:

  1. Non-elective surgery;
  2. Previous surgical operation on the ipsilateral lung;
  3. Pregnant or lactating women;
  4. Patients who, in the judgment of the investigator, are unsuitable to participate in the study for other reasons.

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: Ezisurg stapler
Device: thoracic surgery
thoracic surgery using the easyEndo™ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomosis success rate
Time Frame: Perioperative/Periprocedural
Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed.
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
intra-operative blood loss
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
post-operative air leak
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
incidence of conversion to open surgery due to stapler-related issues
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
complication
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.

Collaborators

Jinhua Municipal Central Hospital

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)

June 11, 2024

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

September 27, 2024

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JH-Lite-T

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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