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Completed

NCT Number: NCT07361939

easyEndoTM Lite Stapler 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.

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Key information

Conditions

Gastrointestinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saida Center, Lebanon

Beirut, 1104, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

Device

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.

Primary outcomes

  1. stapling success rate

    Time frame: Perioperative/Periprocedura

Secondary outcomes

  1. postoperative complications

    Time frame: Perioperative/Periprocedural

  2. 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

Sponsors and collaborators

Lead sponsor

Ezisurg Medical Co. Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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