Disposable endoscopic linear cutter stapler
Wujin District, Changzhou, China
Not Yet Recruiting
NCT Number: NCT06677008
Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Disposable endoscopic linear cutter stapler
DeviceInvestigational devices of all the models of the staplers and its cartridge listed in Study Plan(Plan number: CAK-PMCF)
Primary outcomes
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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.
Secondary outcomes
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Operation time
Time frame: The investigation sites will be collected from January 2023 to September 2024.
Confirmed by surgical records and anesthesia sheets.
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Amount of intraoperative blood loss
Time frame: the investigation sites will be collected from January 2023 to September 2024.
Confirmed by surgical records/nursing notes.
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Intraoperative conversion (caused by the stapler and/or cartridge)
Time frame: the investigation sites will be collected from January 2023 to September 2024.
Surgical records confirm the intraoperative conversion, and determine whether the intraoperative conversion is caused by the investigational devices according to the description.
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Length of hospitalization
Time frame: the investigation sites will be collected from January 2023 to September 2024.
Records were collected for the patient's date of surgery and date of discharge .
Length of hospitalization(days) = date of discharge - date of surgery
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All-cause re-hospitalization rate (within 6 months)
Time frame: From the date of surgery to six months after the surgery
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%
Other outcomes
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Adverse events
Time frame: From the date of surgery to six months after the surgery
Common adverse events due to the device and treatment were: anastomotic leakage, bleeding, stenosis, fistula, infection, etc.
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Device deficiencies
Time frame: From the date of surgery to six months after the surgery
Inadequacy of medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.
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Serious adverse events
Time frame: From the date of surgery to six months after the surgery
Incidence of serious adverse events = Number of serious adverse events/number of enrolled cases ×100%
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Suzhou Care-Real Medical Technology Co., Ltd.
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Nov 6, 2024
- Registry last updated
- Nov 6, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.