Clinical trial NCT06677008: Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
Official title: Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: The Expeditious Transection/resection of Tissues and Creation of Anastomoses
Lead sponsor: Suzhou Kerui Medical Technology Co., Ltd
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 soft tissue resection, transection and anastomosis.


Eligibility criteria: 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.

Primary outcomes:
measure: Anastomosis success rate
timeFrame: the investigation sites will be collected from January 2023 to September 2024.
Secondary outcomes:
measure: Operation time
timeFrame: The investigation sites will be collected from January 2023 to September 2024.
measure: Amount of intraoperative blood loss
timeFrame: the investigation sites will be collected from January 2023 to September 2024.
measure: Intraoperative conversion (caused by the stapler and/or cartridge)
timeFrame: the investigation sites will be collected from January 2023 to September 2024.
measure: Length of hospitalization
timeFrame: the investigation sites will be collected from January 2023 to September 2024.
measure: All-cause re-hospitalization rate (within 6 months)
timeFrame: From the date of surgery to six months after the surgery
Other outcomes:
measure: Adverse events
timeFrame: From the date of surgery to six months after the surgery
measure: Device deficiencies
timeFrame: From the date of surgery to six months after the surgery
measure: Serious adverse events
timeFrame: From the date of surgery to six months after the surgery
Locations:
city: Wujin District
country: China
facility: Disposable endoscopic linear cutter stapler
state: Changzhou
Study officials:
References: