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

Ezisurg Medical Co. Ltd.

Status

Completed

Conditions

Thyroid Cancer

Treatments

Device: Ultrasonic Surgical System

Device: HARMONIC System

Study type

Interventional

Funder types

Other

Identifiers

NCT07235553

US1-080002A

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.