NCT07361939

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 17, 2025

Last Update Submit

January 14, 2026

Conditions

Gastrointestinal Surgery

Outcome Measures

Primary Outcomes (1)

  • stapling success rate

    Perioperative/Periprocedura

Secondary Outcomes (2)

  • postoperative complications

    Perioperative/Periprocedural

  • Technical success rate

    Perioperative/Periprocedural

Study Arms (1)

easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

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

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.

easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saida Center, Lebanon

Beirut, Beyrouth, 1104, Lebanon

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 23, 2026

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)