the Transection of TissuesNCT07028554
Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
An observational study of the Transection of Tissues and the Resection of Tissues, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in Chile.
Trial summary
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Transection of Tissues, the Resection of Tissues, the Creation of Anastomoses
- What is being tested?
- Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChile
- Study dates
- 10 Jan 2025to 15 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Cartridges of Disposable Endoscopic Linear Cutting Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments are applied in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. They must be used in combination with Disposable Powered Endoscopic Linear Cutting Staplers or Disposable Endoscopic Linear Cutting Staplers manufactured by the Company.
Who may be able to join
- Age≥18 years old, gender unlimited;
- The surgery type shall be open or endoscopic surgery;
- The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
- Investigational devices listed in this PMCF plan must be used during surgical procedures.
Who cannot join
- Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
- Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
- The operation record is incomplete, and the information related to the main indicators cannot be extracted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Cartridges of Disposable Endoscopic Linear Cutting Staplers
Ningbo, Zhejiang, 315101
Mi Zhao, +8618317178013, zhaomi@nbverykind.com
About this study
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures.
In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.
- Being tested
- Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable PoweredDevice
Investigational devices encompassing all models of the Cartridges for Disposable Endoscopic Linear Cutting Staplers, as well as Staplers utilized in conjunction with the Cartridges specified in the Study Plan (Plan number: WEKD-QS-PMCF).
| Study group | Role | What they receive |
|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers | Investigational devices are Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. Receives: Device: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis success rate
According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.
Measured: The investigation sites will be collected from January 2023 to June 2024.
Secondary outcomes (3)
Anastomotic bleeding rate
Measured: The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.
Anastomotic leakage rate
Measured: The incidence of leakage during day of operation and 6 months after operation was recorded.
Anastomotic stenosis rate
Measured: The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start10 Jan 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Transection of TissuesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028554
- Sponsor's protocol ID
- WEKD-QS-PMCF
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 19 Jun 2025
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study Plan for Cartridges of Disposable Endoscopic Linear Cutting Staplers
- ClinicalTrials.gov ID
- NCT07028554
- Acronym / sponsor ID
- WEKD-QS-PMCF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 19 Jun 2025 (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.
Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. have marketed in many countries or area for many years. The investigational devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures.
In order to confirm the safety and performance of the products, as well as the continued safety and clinical performance of the implant (the staple) during the clinical follow-up period, monitor the identified side-effects, contraindications and identify previously unknown side-effects, and ensure the continued acceptability of the benefit-risk ratio, Investigators proactively collect and evaluate clinical data from different regions, including of Italy, Brazil and Chile, where the device has been marketed, and conduct PMCF studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers | – | Device: Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable PoweredInvestigational devices are Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable Powered Endoscopic Linear Cutting Staplers and Disposable Endoscopic Linear Cutting Staplers manufactured by Ningbo Verykind Medical Device Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cartridges of Disposable Endoscopic Linear Cutting Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments are applied in multiple open or minimally invasive general, gynecologic, urologic and thoracic surgical procedures. They must be used in combination with Disposable Powered Endoscopic Linear Cutting Staplers or Disposable Endoscopic Linear Cutting Staplers manufactured by the Company.
Key inclusion criteria (4 listed)
- Age≥18 years old, gender unlimited;
- The surgery type shall be open or endoscopic surgery;
- The departments of surgical procedures: general, gynecologic, urologic and thoracic surgical procedures;
- Investigational devices listed in this PMCF plan must be used during surgical procedures.
Key exclusion criteria (3 listed)
- Patients with surgical contraindications to the product, e.g. use the instruments on large arteries, on ischemic or necrotic tissue, use the device on tissues with a compression thickness out of the device range;
- Concomitant with similar devices (staplers/reloads/cartridges, etc.) for resection, transection and anastomosis of surgical organ or tissues;
- The operation record is incomplete, and the information related to the main indicators cannot be extracted.
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 |
|---|---|---|
| Cartridges of Disposable Endoscopic Linear Cutting Staplers, Disposable PoweredInvestigational devices encompassing all models of the Cartridges for Disposable Endoscopic Linear Cutting Staplers, as well as Staplers utilized in conjunction with the Cartridges specified in the Study Plan (Plan number: WEKD-QS-PMCF). | Device | Cartridges of Disposable Endoscopic Linear Cutting Staplers |
Primary outcome
Anastomosis success rate
Time frame: The investigation sites will be collected from January 2023 to June 2024.
According to surgical records and inpatient medical records, no reoperation in situ is defined as successful anastomosis.
3 secondary outcomes
Anastomotic bleeding rate
Time frame: The incidence of anastomotic bleeding during day of operation and 6 months after operation was recorded.
Anastomotic leakage rate
Time frame: The incidence of leakage during day of operation and 6 months after operation was recorded.
Anastomotic stenosis rate
Time frame: The incidence of anastomotic stenosis during day of operation and 6 months after operation was recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Transection of Tissues and the Resection of Tissues, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in Chile.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Zhou (+86 18118447767, ke.zhou@care-real.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis success rate (time frame: The investigation sites will be collected from January 2023 to June 2024.). 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 19 Jun 2025.