Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System
NCT ID: NCT07235553
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2017-03-28
2018-02-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultrasonic Surgical System
Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
Ultrasonic Surgical System
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
HARMONIC System
HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
HARMONIC System
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
Interventions
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Ultrasonic Surgical System
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
HARMONIC System
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Peking University Third Hospital
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Ezisurg Medical Co. Ltd.
OTHER
Responsible Party
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Principal Investigators
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Ben Wan
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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US1-080002A
Identifier Type: -
Identifier Source: org_study_id
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