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

NCT07235553 | Completed

• 1 other identifier: US1-080002A
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ultrasonic Surgical System

EXPERIMENTAL

Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01

Device: Ultrasonic Surgical System

HARMONIC System

ACTIVE COMPARATOR

HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054

Device: HARMONIC System

Interventions

Ultrasonic Surgical System DEVICE

Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01

Ultrasonic Surgical System

HARMONIC System DEVICE

Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054

HARMONIC System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ezisurg Medical Co. Ltd.: lead
• Beijing Hospital: collaborator
• Peking University Third Hospital: collaborator
• China-Japan Union Hospital, Jilin University: collaborator

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Ben Wan

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, multi-center, randomized, parallel-controlled, non-inferiority study.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: March 28, 2017
• Primary Completion: January 5, 2018
• Study Completion: February 5, 2018
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)