easyEndoTM Powered Stapler Study

Ezisurg Medical Co. Ltd.

Status: Completed

Conditions: Bariatric Surgery

Treatments: Device: laparoscopic bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07375017

PS-BS-QA

Details and patient eligibility

About

The goal of this Observational, retrospective, uncontrolled is to evaluate the safety and performance of the easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges from EziSurg Medical used in laparoscopic bariatric surgery.. The main question it aims to answer the safety and performance of the device

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients have undergone laparoscopic bariatric surgery.
• The operation involves the application of easyEndo™ Powered Staplers and Cartridges for tissue cutting and suturing.

Exclusion criteria

• Pregnancy.
• Emergency operation (such as acute intestinal obstruction and gastrointestinal perforation).
• Assessed by the investigator, whose condition is poor and cannot tolerate the surgery.
• History of gastrointestinal surgery.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

easyEndo™ Powered Single Use Powered Endoscopic Staplers and Cartridges

Experimental group

Description:

The easyEndoTM Powered Single Use Powered Endoscopic Staplers and Cartridges, which used together, are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

Treatment:

Device: laparoscopic bariatric surgery