easyEndoTM Lite Stapler Study

N/ACompletedNCT07361939

Ezisurg Medical Co. Ltd.156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Gastrointestinal Surgery

Interventions

easyEndoTM Lite Linear Cutting Stapler and staggered design Loading UnitDEVICE

The Staplers are available in 260mm, 350mm and 440mm lengths. Loading Units for Single Use are available in eight staple sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 2.0-2.5-3.5mm and 3.5-3.8-4.1mm, 3.8-4.1-4.4mm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Saida Center, Lebanon

Beirut, Beyrouth, Lebanon

Outcomes

Primary Outcomes

stapling success rate

Time frame: Perioperative/Periprocedura

Secondary Outcomes

postoperative complications

Time frame: Perioperative/Periprocedural

Technical success rate

defined as completion of gastrointestinal surgery as intended without technical difficulties and/or without conversion to open laparotomy

Time frame: Perioperative/Periprocedural

Data from ClinicalTrials.gov

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