easyEndoTM Lite Stapler Study

January 14, 2026 updated by: Ezisurg Medical Co. Ltd.

Evaluation of the Safety and Effectiveness of easyEndoTM Lite Linear Cutting Stapler and Loading Unit in Gastrointestinal Surgery: a Retrospective, Observational, Post Market Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
    • Beyrouth
      • Beirut, Beyrouth, Lebanon, 1104
        • Saida Center, Lebanon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
Device: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stapling success rate
Time Frame: Perioperative/Periprocedura
Perioperative/Periprocedura

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: Perioperative/Periprocedural
Perioperative/Periprocedural
Technical success rate
Time Frame: Perioperative/Periprocedural
defined as completion of gastrointestinal surgery as intended without technical difficulties and/or without conversion to open laparotomy
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ezisurg Medical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Lite-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Surgery

Clinical Trials on easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe