The objective of this clinical investigation is to evaluate the efficacy and safety of the Ultrasonic Surgical System in the clinical application produced by Ezisurg Medical Co., Ltd.
This clinical investigation is designed as a prospective, multi-center, randomized, parallel-controlled non-inferiority investigation, and the HARMONIC System produced by Ethicon Endo-Surgery, LLC is used as the control product. Study objective:To evaluate the efficacy and safety of the Ultrasonic Surgical System in the clinical application produced by Ezisurg Medical Co., Ltd. Target population:Patients who require open or endoscopic surgery using the Ultrasonic Surgical Instruments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
Beijing Hospital
Beijing, Beijing Municipality, China
The overall excellent performance rate
The overall excellent performance rate will be taken as the primary evaluation indicator. The clinical effect of the investigational product is mainly embodied by its cutting and coagulation functions, and the surgical operators will evaluate the cutting and coagulation functions of the product according to the following criteria.
Time frame: during the surgery
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