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

NCT07354854 | Completed

• 1 other identifier: JH-Lite-T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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  Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage.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 Outcomes (5)

• 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

Study Arms (1)

Ezisurg stapler

EXPERIMENTAL

Device: thoracic surgery

Interventions

thoracic surgery DEVICE

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

Ezisurg stapler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ezisurg Medical Co. Ltd.: lead
• Jinhua Municipal Central Hospital: collaborator

Study Sites (1)

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Interventions

Thoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 21, 2026
• Study Start: June 11, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)