Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System

November 17, 2025 updated by: Ezisurg Medical Co. Ltd.

A Prospective, Multi-center, Randomized, Open-label, Parallel-controlled Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System in Clinical Applications

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonic Surgical System
Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
Device: Ultrasonic Surgical System
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
Active Comparator: HARMONIC System
HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
Device: HARMONIC System
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall excellent performance rate
Time Frame: 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.
during the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ezisurg Medical Co. Ltd.

Collaborators

Peking University Third Hospital
Beijing Hospital
China-Japan Union Hospital, Jilin University

Investigators

  • Principal Investigator: Ben Wan, Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

January 5, 2018

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US1-080002A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

began enrolling participants beforeJanuary 1, 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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