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

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: Lung Cancer (Diagnosis)
• Intervention / Treatment: Device: thoracic surgery

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321000
      • Jinhua Municipal Central Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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Anastomosis success rate	Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage.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	Perioperative/Periprocedural
intra-operative blood loss	Perioperative/Periprocedural
post-operative air leak	Perioperative/Periprocedural
incidence of conversion to open surgery due to stapler-related issues	Perioperative/Periprocedural
complication	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: Ezisurg Medical Co. Ltd.
• Collaborators: Jinhua Municipal Central Hospital

Study record dates

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: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Surgical Procedures, Operative; Thoracic Surgical Procedures
• 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