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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSuzhou Care-Real Medical Technology Co., Ltd.

About this trial

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

Qualifiers

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.

Disqualifiers

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 design

Treatments tested in this trial

  • Disposable endoscopic linear cutter stapler

Treatment groups

302 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Disposable endoscopic linear cutter stapler Status unavailable Wujin District, ChangzhouChinaChina