easyEndoTM Lite Stapler Study

Ezisurg Medical Co. Ltd.

Status: Completed

Conditions: Gastrointestinal Surgery

Treatments: Device: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

Study type: Interventional

Funder types: Other

Identifiers

NCT07361939

Lite-T

Details and patient eligibility

About

The purpose of this observational study is to evaluate the safety and performance of the easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit from EziSurg Medical in gastrointestinal surgery. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications retrospectively.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age at study entry is at least 18 years.
• The operation involves the application of easyEndoTM Lite Stapler and Loading Unit for tissue cutting and suturing.

Exclusion criteria

• Pregnancy.
• Emergency operation (such as acute intestinal obstruction and gastrointestinal perforation).
• Assessed by the investigator, whose condition is poor and cannot tolerate the surgery.
• History of gastrointestinal surgery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

Experimental group

Treatment:

Device: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit