Lung CancerNCT05329402

Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

A study testing Disposable Powered Articulating Endoscopic Linear Cutter Stapler and ECHELON Flex Powered Articulating Endoscopic Linear Cutters in people with Lung Cancer, run by Fengh Medical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by Johnson \& Johnson when the Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Thoracoscopic Anatomic Lobectomy (segmentectomy) Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Lung Cancer
What is being tested?: Disposable Powered Articulating Endoscopic Linear Cutter Stapler and ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteChina
Study dates: 22 Oct 2018to 5 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects aged 18-70 (inclusive), with no gender limitation;
The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment);
Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.

Who cannot join

Subjects have contraindications of video-assisted thoracoscopy;
The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes;
Subjects' platelet (PLT) <60x 10%/L or INR > 1.5;
Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%;
Cardiac ejection fraction ≤50%;
Major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) Myocardial infarction; A history of severe neurological or psychiatric illness; The presence of a serious infection before surgery that must be controlled with medication; Dissemination of activity Sexual intravascular coagulation; At high risk of blood clots);

Show all 9Show fewer

The subject is a pregnant or lactating woman;
The subject participated in clinical trials of other drugs or devices within 1 month prior to the trial;
Other conditions that the researcher judged inappropriate for inclusion. .

Trial locations and contacts

1 site in 1 country.

China1 site

Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Jiangyin, Jiangsu, 214437

Other trials in China

About this study

Official title: Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)

Read the detailed description

By comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter stapler and cartridge (the subject product) produced by Jiangsu Fengh Medical Co., Ltd. and the similar product (electric-endoscopic linear cutter stapler with articulating head) produced by Johnson \& Johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to prove that the subject product can be used for pulmonary tissue resection and anastomosis, and that the clinical trial meets the requirements of Good Clinical Practice for Medical Devices, Guidelines for Clinical Trial Design of Medical Devices and Guidelines for Technical Review of Endoscopic Stapler Registration, which can be used for product registration application.

Conditions: Lung Cancer
Being tested: Disposable Powered Articulating Endoscopic Linear Cutter Stapler, ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Disposable Powered Articulating Endoscopic Linear Cutter StaplerDevice
Using the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment
ECHELON Flex Powered Articulating Endoscopic Linear CuttersDevice
Using the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment

Study groups in NCT05329402
Study group	Role	What they receive
Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Experimental	Disposable Powered Articulating Endoscopic Linear Cutter Stapler Receives: Device: Disposable Powered Articulating Endoscopic Linear Cutter Stapler
ECHELON Flex Powered Articulating Endoscopic Linear Cutters	Active comparator	ECHELON Flex Powered Articulating Endoscopic Linear Cutters Receives: Device: ECHELON Flex Powered Articulating Endoscopic Linear Cutters

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Anastomosis Success
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure.
Measured: During surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 20185 Mar 2020

First posted15 Apr 2022
Study start22 Oct 2018
Primary completion11 Sep 2019
Study completion5 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05329402
Sponsor's protocol ID: 20256031708-BC1
Status last verified: Nov 2023
First submitted: 31 Mar 2022
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only the results of CT, routine blood test, coagulation function, fasting blood glucose, occult blood test of stool, cardiac ultrasound, lung function and digestive tract angiography were available to the participants, and other results were not shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial on Performance and Safety of Disposable Powered Articulating Linear Cutter Stapler and Reloads in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
ClinicalTrials.gov ID: NCT05329402
Acronym / sponsor ID: 20256031708-BC1
Conditions: Lung Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Fengh Medical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Oct 2018 (actual)
Primary completion: 11 Sep 2019 (actual)
Study completion: 5 Mar 2020 (actual)
First posted: 15 Apr 2022 (actual)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Disposable Powered Articulating Endoscopic Linear Cutter Stapler	Experimental	Device: Disposable Powered Articulating Endoscopic Linear Cutter StaplerDisposable Powered Articulating Endoscopic Linear Cutter Stapler
ECHELON Flex Powered Articulating Endoscopic Linear Cutters	Active comparator	Device: ECHELON Flex Powered Articulating Endoscopic Linear CuttersECHELON Flex Powered Articulating Endoscopic Linear Cutters

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects aged 18-70 (inclusive), with no gender limitation;
The subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment);
Subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent.

Key exclusion criteria (9 listed)

Subjects have contraindications of video-assisted thoracoscopy;
The preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes;
Subjects' platelet (PLT) <60x 10%/L or INR > 1.5;
Subjects forced expiratory volume in 1 second (FEV1)/expected value ≤50%, or forced expiratory volume in 1 second (FEV1)/use Vital capacity (FVC)≤60%;
Cardiac ejection fraction ≤50%;

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
Disposable Powered Articulating Endoscopic Linear Cutter StaplerUsing the Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to routine treatment	Device	Disposable Powered Articulating Endoscopic Linear Cutter Stapler
ECHELON Flex Powered Articulating Endoscopic Linear CuttersUsing the ECHELON Flex Powered Articulating Endoscopic Linear Cutters according to routine treatment	Device	ECHELON Flex Powered Articulating Endoscopic Linear Cutters

Primary outcome

Number of Participants With Anastomosis Success
Time frame: During surgery
The transection and anastomosis of lung tissues are performed during the operation. The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity, air leakage and bleeding. If all staple lines are complete, without air leakage or bleeding, it is judged that the cutting and anastomosis of the device is successful. If there is persistent air leakage and bleeding at the anastomosis site, and conversion to thoracotomy is required, it is judged as device cutting and anastomosis failure.

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Disposable Powered Articulating Endoscopic Linear Cutter Stapler	80	79
ECHELON Flex Powered Articulating Endoscopic Linear Cutters	84	83

Primary outcome: Number of Participants With Anastomosis Success

Time frame: During surgery. Count of participants. Unit: Participants

Measure	Disposable Powered Articulating Endoscopic Linear Cutter Stapler n = 79	ECHELON Flex Powered Articulating Endoscopic Linear Cutters n = 83
Value	79	83

Disposable Powered Articulating Endoscopic Linear Cutter Stapler vs ECHELON Flex Powered Articulating Endoscopic Linear Cutters: Mean Difference (Final Values): 0 (95% CI -0.0285 to 0.0273), p = 0.9727, Wald

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Disposable Powered Articulating Endoscopic Linear Cutter Stapler	10 of 79 (12.7%)	44 of 79 (55.7%)	0 of 79
ECHELON Flex Powered Articulating Endoscopic Linear Cutters	8 of 83 (9.6%)	54 of 83 (65.1%)	0 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Only the results of CT, routine blood test, coagulation function, fasting blood glucose, occult blood test of stool, cardiac ultrasound, lung function and digestive tract angiography were available to the participants, and other results were not shared

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RecruitingObservational study
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Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung
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KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
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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.

Yusheng Shu principal investigator

Northern Jiangsu People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 2 May 2024. 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?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Anastomosis Success (time frame: During surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329402.

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 2 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.