Gastrointestinal NeoplasmNCT05320029
Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
A study testing Disposable Powered Articulating Endoscopic Linear Cutter Stapler and ECHELON Flex Powered Articulating Endoscopic Linear Cutters in people with Gastrointestinal Neoplasm, run by Fengh Medical Co., Ltd. at 1 site in China.
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 Gastrointestinal Tissue Cutting and Anastomosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neoplasm
- 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
- 30 Aug 2018to 20 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects are 18 ~ 75 years old, regardless of gender:
- Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:
- The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent.
Who cannot join
- The subject plans to perform emergency gastrointestinal surgery:
- Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g / L):
- Subject BMI 228kg / m2;
- Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;
- Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;
- Subject's cardiac ejection fraction ≤ 50%;
Show all 11Show fewer
- Have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) Transferase (AST), or alanine aminotransferase (ALT), or serum creatinine (SER) exceeds normal values
- Upper limit 3 times and above: subjects with fasting blood glucose value > 10.0mmol/l before operation:
- The subjects were pregnant or lactating women; Page 16 of 53 Version No.: 1.1/version date 20190125 Clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue
- Subjects participated in clinical trials of other drugs or devices within 3 months before the trial;
- Other conditions that the researchers judged not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Disposable Powered Articulating Endoscopic Linear Cutter Stapler
Jiangyin, Jiangsu, 214437
About this study
Official title: Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
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 Gastrointestinal Tissue Cutting and Anastomosis
Read the detailed description
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson \& Johnson.
- Conditions
- Gastrointestinal Neoplasm
- Being tested
- Disposable Powered Articulating Endoscopic Linear Cutter Stapler, ECHELON Flex Powered Articulating Endoscopic Linear Cutters
- Medical subject headings
- Gastrointestinal 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 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. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as 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.
- First posted11 Apr 2022
- Study start30 Aug 2018
- Primary completion11 Feb 2020
- Study completion20 Jan 2022
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 Gastrointestinal NeoplasmStudies 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
- Model description
- Patients randomized to the trial group and the control group will not cross use the product
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fengh Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Ni, Principal investigator, First People's Hospital of Yangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320029
- Sponsor's protocol ID
- 20256031708
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2022
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants can only see the results of CT, blood routine, coagulation function, fasting blood glucose, fecal occult blood test, cardiac ultrasound, pulmonary function and gastrointestinal angiography, and the other results are not shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
- ClinicalTrials.gov ID
- NCT05320029
- Acronym / sponsor ID
- 20256031708
- Conditions
- Gastrointestinal Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Fengh Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Posted 24 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Gastrointestinal Tissue Cutting and Anastomosis
Detailed description
In this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Jiangsu Fengh Medical Co., Ltd. when used for gastrointestinal tissue cutting and anastomosis. To determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by Johnson \& Johnson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomized to the trial group and the control group will not cross use the product
| 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subjects are 18 ~ 75 years old, regardless of gender:
- Subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis:
- The subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol And sign informed consent.
Key exclusion criteria (11 listed)
- The subject plans to perform emergency gastrointestinal surgery:
- Subjects with moderate malnutrition (BML < 17kg / m2) and severe anemia (HB < 60g / L):
- Subject BMI 228kg / m2;
- Subject platelet (PLT) < 60x 109 / L or international normalized ratio (INR) > 1.5;
- Subject forced expiratory volume per second (FEV1) / expected value ≤ 50%, or forced expiratory volume per second (FEV1) / forced vital capacity (FCV) < 60%;
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. Anastomosis is considered as successful if all anastomotic rings are intact without leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Participants can only see the results of CT, blood routine, coagulation function, fasting blood glucose, fecal occult blood test, cardiac ultrasound, pulmonary function and gastrointestinal angiography, and the other results are not shared
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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.
Qing Ni principal investigator
First People's Hospital of Yangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable Powered Articulating Endoscopic Linear Cutter Stapler and ECHELON Flex Powered Articulating Endoscopic Linear Cutters in people with Gastrointestinal Neoplasm, run by Fengh 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 11 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 14 Dec 2023. 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 24 Nov 2023). 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?
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 14 Dec 2023.