Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

N/ANot Yet RecruitingNCT06677008

Suzhou Care-Real Medical Technology Co., Ltd.302 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

302

Conditions

The Expeditious Transection/resection of Tissues and Creation of Anastomoses

Interventions

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)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Disposable endoscopic linear cutter stapler

Wujin District, Changzhou, China

Outcomes

Primary Outcomes

Anastomosis success rate

The condition of no reoperation in situ was defined as successful anastomosis as determined by surgical records and hospitalization medical records.

Time frame: the investigation sites will be collected from January 2023 to September 2024.

Secondary Outcomes

Operation time

Confirmed by surgical records and anesthesia sheets.

Time frame: The investigation sites will be collected from January 2023 to September 2024.

Amount of intraoperative blood loss

Confirmed by surgical records/nursing notes.

Time frame: 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.

Time frame: 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

Time frame: 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%

Time frame: From the date of surgery to six months after the surgery

Central Contacts

Ke Zhou

CONTACT

+86 18118447767 ke.zhou@care-real.com

Data from ClinicalTrials.gov

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