Thyroid CancerNCT07235553
Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System
A study testing Ultrasonic Surgical System and HARMONIC System in people with Thyroid Cancer, run by Ezisurg Medical Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Ultrasonic Surgical System and HARMONIC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2017to 5 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- Ultrasonic Surgical System, HARMONIC System
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Surgical SystemDevice
Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
HARMONIC SystemDevice
Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Surgical System | Experimental | Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 Receives: Device: Ultrasonic Surgical System |
| HARMONIC System | Active comparator | HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 Receives: Device: HARMONIC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start28 Mar 2017
- Primary completion5 Jan 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multi-center, randomized, parallel-controlled, non-inferiority study.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezisurg Medical Co. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Peking University Third Hospital, China-Japan Union Hospital, Jilin University
- Responsible party
- Sponsor
- Investigators
- Ben Wan, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235553
- Sponsor's protocol ID
- US1-080002A
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: began enrolling participants beforeJanuary 1, 2019
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07235553
- Acronym / sponsor ID
- US1-080002A
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ezisurg Medical Co. Ltd.University, hospital or other
- Collaborators
- Beijing Hospital, Peking University Third Hospital, China-Japan Union Hospital, Jilin University
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multi-center, randomized, parallel-controlled, non-inferiority study.
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Surgical System | Experimental | Device: Ultrasonic Surgical SystemUltrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 |
| HARMONIC System | Active comparator | Device: HARMONIC SystemHARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Surgical SystemGenerator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 | Device | Ultrasonic Surgical System |
| HARMONIC SystemGenerator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 | Device | HARMONIC System |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. began enrolling participants beforeJanuary 1, 2019
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Wan principal investigator
Beijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Surgical System and HARMONIC System in people with Thyroid Cancer, run by Ezisurg Medical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall excellent performance rate (time frame: during the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.