Thyroid Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasonic Surgical System
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
DEVICEHARMONIC System
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
Sponsors
Beijing Hospital
Peking University Third Hospital
China-Japan Union Hospital, Jilin University
Ezisurg Medical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective, multi-center, randomized, parallel-controlled, non-inferiority study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who voluntarily participate in the investigation and sign the Informed Consent Form; * Male or female subjects aged 18\ 75; * Patients who require open or endoscopic surgery using the Ultrasonic Surgical System; * Those who can communicate well with investigators and comply with investigational requirements.
Exclusion criteria
* Patients with severe heart, liver, lung, kidney, brain, blood system diseases, severe metabolic diseases or unable to withstand surgery after systemic assessment; * Those who with obvious severe local or systemic infection; * Those who need to undergo the resection of bone tissue and central nervous tissue of the brain and the spinal cord; * Those who need to undergo contraceptive tubal ligation; * Those who have a history of alcohol or drug abuse within 6 months before the investigation; * Women who are pregnant or lactating, or women who plan to become pregnant within 6 months; * Those who with mental illness; * Those who have a history of allergies to multiple types of drugs or recent allergic diseases; * Those who have participated in other clinical investigations in the past 3 months; * Those who are inappropriate to participate in this clinical investigation for other reasons in the opinion of the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall excellent performance rate | during the surgery | 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. |
Countries
China
Outcome results
None listed