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

Ezisurg Medical Co. Ltd.

Status: Completed

Conditions: Lung Cancer (Diagnosis)

Treatments: Device: thoracic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07354854

JH-Lite-T

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ezisurg stapler

Experimental group

Treatment:

Device: thoracic surgery