The Expeditious Transection/resection of Tissues and Creation of AnastomosesNCT06677008
Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
An observational study of The Expeditious Transection/resection of Tissues and Creation of Anastomoses, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Expeditious Transection/resection of Tissues and Creation of Anastomoses
- What is being tested?
- Disposable endoscopic linear cutter stapler
- Type of treatment
- Medical device
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 28 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.
Who may be able to join
- Age unlimited and gender unlimited;
- The surgery type shall be endoscopic surgery;
- The departments of surgical procedures: general and thoracic surgical procedures;
- Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.
Who cannot join
- Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
- Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
- Surgery record is incomplete, unable to extract main indicators related information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Disposable endoscopic linear cutter stapler
Wujin District, Changzhou
Xiaohong Xu, +86 13915015530, xuxiaohong@czakyl.com
About this study
This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.
- Being tested
- Disposable endoscopic linear cutter stapler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable endoscopic linear cutter staplerDevice
Investigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)
| Study group | Role | What they receive |
|---|---|---|
| Disposable endoscopic linear cutter stapler | Not described Receives: Device: Disposable endoscopic linear cutter stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis success rate
The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.
Measured: the investigation sites will be collected from January 2023 to September 2024.
Secondary outcomes (5)
Operation time
Confirmed by surgical records and anesthesia sheets.
Measured: The investigation sites will be collected from January 2023 to September 2024.
Amount of intraoperative blood loss
Confirmed by surgical records/nursing notes.
Measured: the investigation sites will be collected from January 2023 to September 2024.
Intraoperative conversion (caused by the stapler and/or cartridge)
Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description.
Measured: the investigation sites will be collected from January 2023 to September 2024.
Length of hospitalization
Records were collected for the patient's date of surgery and date of discharge .
Length of hospitalization(days) = date of discharge - date of surgery
Measured: the investigation sites will be collected from January 2023 to September 2024.
All-cause re-hospitalization rate (within 6 months)
Re-hospitalization data of patients within 6 months after surgery were collected.
Postoperative all-cause re-hospitalization rate = number of all-cause re-hospitalization cases/total cases ×100%
Measured: From the date of surgery to six months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Expeditious Transection/resection of Tissues and Creation of AnastomosesStudies 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
- 302 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
- NCT06677008
- Sponsor's protocol ID
- CAK-PMCF
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
- ClinicalTrials.gov ID
- NCT06677008
- Acronym / sponsor ID
- CAK-PMCF
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disposable endoscopic linear cutter stapler | – | Device: Disposable endoscopic linear cutter stapler |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For patients who need to be operated for abdominal, gynecologic, pediatric, and thoracic, endoscopic (i.e., endo-therapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses.
Key inclusion criteria (4 listed)
- Age unlimited and gender unlimited;
- The surgery type shall be endoscopic surgery;
- The departments of surgical procedures: general and thoracic surgical procedures;
- Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.
Key exclusion criteria (3 listed)
- Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
- Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
- Surgery record is incomplete, unable to extract main indicators related information.
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 endoscopic linear cutter staplerInvestigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF) | Device | Disposable endoscopic linear cutter stapler |
Primary outcome
Anastomosis success rate
Time frame: the investigation sites will be collected from January 2023 to September 2024.
The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.
5 secondary outcomes
Operation time
Time frame: The investigation sites will be collected from January 2023 to September 2024.
Amount of intraoperative blood loss
Time frame: the investigation sites will be collected from January 2023 to September 2024.
Intraoperative conversion (caused by the stapler and/or cartridge)
Time frame: the investigation sites will be collected from January 2023 to September 2024.
Length of hospitalization
Time frame: the investigation sites will be collected from January 2023 to September 2024.
All-cause re-hospitalization rate (within 6 months)
Time frame: From the date of surgery to six months after the surgery
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 6 Nov 2024.
- Individual participant dataSharing planned: No
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 Expeditious Transection/resection of Tissues and Creation of Anastomoses, run by Suzhou Care-Real Medical Technology 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 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: opening soon, as of the sponsor's last update on 6 Nov 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?
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 September 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 6 Nov 2024.