Thoracic SurgeryNCT07345013
easyEndoTM Lite Staplers and Loading Units in Thoracic Surgery
A study testing easyEndoTM Lite linear cutting stapler and loading units in people with Thoracic Surgery, run by Ezisurg Medical Co. Ltd. at 1 site in China.
Trial summary
A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- easyEndoTM Lite linear cutting stapler and loading units
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2021to 1 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
The study population were patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study to Evaluate the Safety and Effectiveness of easyEndoTM Lite Staplers and Loading Units
A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.
- Conditions
- Thoracic Surgery
- Being tested
- easyEndoTM Lite linear cutting stapler and loading units
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 loading unitsDevice
using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| easyEndoTM Lite linear cutting stapler and loading units | Experimental | Not described Receives: Device: easyEndoTM Lite linear cutting stapler and loading units |
What is being measured
The primary outcome is the main question the study is designed to answer.
stapling success rate
No intrate-operative and post-operative air-leak
Measured: Perioperative/Periprocedural
Secondary outcomes (5)
Intraoperative blood loss
Measured: Perioperative/Periprocedural
Rate of convert to open surgery
Measured: Perioperative/Periprocedural
Hospitalization time
Measured: Perioperative/Periprocedural
Incidence of postoperative complications
Measured: Perioperative/Periprocedural
Readmission rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start3 Jan 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic 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
- 900 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
- NCT07345013
- Sponsor's protocol ID
- ESM-MDR-VIII 1006A
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Safety and Effectiveness of easyEndoTM Lite Staplers and Loading Units
- ClinicalTrials.gov ID
- NCT07345013
- Acronym / sponsor ID
- ESM-MDR-VIII 1006A
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Ezisurg Medical Co. Ltd.University, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 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.
A retrospective, single-arm, observation study to Evaluate the clinical safety and performance of Ezisurg stapler in thoracic surgery, 900 patients using the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery from 2021.03-2022.12 in Fujian Medical University Union Hospital. The surgical decision was made by the surgeons, and no other specification restrictions.
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 loading units | Experimental | Device: easyEndoTM Lite linear cutting stapler and loading units |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 loading unitsusing the easyEndoTM Lite linear cutting stapler and loading units during thoracic surgery | Device | easyEndoTM Lite linear cutting stapler and loading units |
Primary outcome
stapling success rate
Time frame: Perioperative/Periprocedural
No intrate-operative and post-operative air-leak
5 secondary outcomes
Intraoperative blood loss
Time frame: Perioperative/Periprocedural
Rate of convert to open surgery
Time frame: Perioperative/Periprocedural
Hospitalization time
Time frame: Perioperative/Periprocedural
Incidence of postoperative complications
Time frame: Perioperative/Periprocedural
Readmission rate
Time frame: 30 days
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 15 Jan 2026.
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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 loading units in people with Thoracic Surgery, run by Ezisurg Medical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 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 China. 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/Periprocedural). 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 15 Jan 2026.