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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Peking University Third Hospital | OTHER |
| China-Japan Union Hospital, Jilin University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic Surgical System | Experimental | Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 |
|
| HARMONIC System | Active Comparator | HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Surgical System | Device | Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Wan | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
began enrolling participants beforeJanuary 1, 2019
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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A prospective, multi-center, randomized, parallel-controlled, non-inferiority study.
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| HARMONIC System | Device | Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 |
|
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |