Lung Cancer (Diagnosis)NCT07354854
Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation
A study testing thoracic surgery in people with Lung Cancer (Diagnosis), run by Ezisurg Medical Co. Ltd. at 1 site in China.
Trial summary
The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications. Participants will undergoing thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- thoracic surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 27 Sep 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
- Older than 18 years old, male or female;
- Subjects are scheduled to undergo open or thoracoscopic puimonary surgery with any surgicalprocedure;
- The surgery is performed using the easyEndotm Lite Linear Cuting Stapler for Single Use andLoading Unites for Single Use for tissue cutting and suturing.
Who cannot join
- Non-elective surgery;
- Previous surgical operation on the ipsilateral lung;
- Pregnant or lactating women;
- Patients who, in the judgment of the investigator, are unsuitable to participate in the study for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications.
Participants will undergoing thoracic surgery.
- Conditions
- Lung Cancer (Diagnosis)
- Being tested
- thoracic surgery
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic surgeryDevice
thoracic surgery using the easyEndo™ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing.
| Study group | Role | What they receive |
|---|---|---|
| Ezisurg stapler | Experimental | Not described Receives: Device: thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis success rate
Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed.
Measured: Perioperative/Periprocedural
Secondary outcomes (5)
operative time
Measured: Perioperative/Periprocedural
intra-operative blood loss
Measured: Perioperative/Periprocedural
post-operative air leak
Measured: Perioperative/Periprocedural
incidence of conversion to open surgery due to stapler-related issues
Measured: Perioperative/Periprocedural
complication
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 posted21 Jan 2026
- Study start11 Jun 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezisurg Medical Co. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354854
- Sponsor's protocol ID
- JH-Lite-T
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 21 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Tri-staple Technology inThoracic Surgery Clinical Investigation
- ClinicalTrials.gov ID
- NCT07354854
- Acronym / sponsor ID
- JH-Lite-T
- Conditions
- Lung Cancer (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ezisurg Medical Co. Ltd.University, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 21 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 goal of this post-market clinical study is to evaluate the safety and effectiveness of the tri-staple technology in thoracic surgery. The main question it aims to answer is to validate its efficacy, safety and operationalperformance for lung applications.
Participants will undergoing thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ezisurg stapler | Experimental | Device: thoracic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years old, male or female;
- Subjects are scheduled to undergo open or thoracoscopic puimonary surgery with any surgicalprocedure;
- The surgery is performed using the easyEndotm Lite Linear Cuting Stapler for Single Use andLoading Unites for Single Use for tissue cutting and suturing.
Key exclusion criteria (4 listed)
- Non-elective surgery;
- Previous surgical operation on the ipsilateral lung;
- Pregnant or lactating women;
- Patients who, in the judgment of the investigator, are unsuitable to participate in the study for other reasons.
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 |
|---|---|---|
| thoracic surgerythoracic surgery using the easyEndo™ Lite Linear Cuting Stapler for Single Use and Loading Unites for Single Use for tissue cutting and suturing. | Device | Ezisurg stapler |
Primary outcome
Anastomosis success rate
Time frame: Perioperative/Periprocedural
Tissue transection andanastomosis are performed during the procedure, and the device is withdrawn after a successful trigger, and the cutting anastomosis line is carefully checked for integrity and air leakage. if the anastomosis is complete and there is no air leakage, the anastomosis is considered successful.other wise it is considered failed.
5 secondary outcomes
operative time
Time frame: Perioperative/Periprocedural
intra-operative blood loss
Time frame: Perioperative/Periprocedural
post-operative air leak
Time frame: Perioperative/Periprocedural
incidence of conversion to open surgery due to stapler-related issues
Time frame: Perioperative/Periprocedural
complication
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 21 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 thoracic surgery in people with Lung Cancer (Diagnosis), 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.
Who may be eligible to take part?
The sponsor lists 3 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 21 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?
Anastomosis 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 21 Jan 2026.