Gastrointestinal SurgeryNCT07361939
easyEndoTM Lite Stapler Study
A study testing easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit in people with Gastrointestinal Surgery, run by Ezisurg Medical Co. Ltd. at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Surgery
- What is being tested?
- easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Mar 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Gastrointestinal Surgery
- Being tested
- easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit | Experimental | Not described Receives: Device: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
stapling success rate
Measured: Perioperative/Periprocedura
Secondary outcomes (2)
postoperative complications
Measured: Perioperative/Periprocedural
Technical success rate
defined as completion of gastrointestinal surgery as intended without technical difficulties and/or without conversion to open laparotomy
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Mar 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezisurg Medical Co. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361939
- Sponsor's protocol ID
- Lite-T
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07361939
- Acronym / sponsor ID
- Lite-T
- Conditions
- Gastrointestinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ezisurg Medical Co. Ltd.University, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit | Experimental | Device: easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| easyEndoTM Lite Linear Cutting Stapler and staggered design Loading UnitThe 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. | Device | easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit |
Primary outcome
stapling success rate
Time frame: Perioperative/Periprocedura
2 secondary outcomes
postoperative complications
Time frame: Perioperative/Periprocedural
Technical success rate
Time frame: Perioperative/Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing easyEndoTM Lite Linear Cutting Stapler and staggered design Loading Unit in people with Gastrointestinal Surgery, run by Ezisurg Medical Co. Ltd. at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stapling success rate (time frame: Perioperative/Periprocedura). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.