NCT07354854CompletedNot Applicable
Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation
Ezisurg Medical Co. Ltd.0 sites30 target enrollmentStarted: June 11, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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