Trials / Completed
CompletedNCT07235553
Non-inferiority Investigation to Evaluate the Efficacy and Safety of the Ultrasonic Surgical System
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Ezisurg Medical Co. Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ultrasonic Surgical System | Generator: ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01 |
| DEVICE | HARMONIC System | Generator: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054 |
Timeline
- Start date
- 2017-03-28
- Primary completion
- 2018-01-05
- Completion
- 2018-02-05
- First posted
- 2025-11-19
- Last updated
- 2025-11-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07235553. Inclusion in this directory is not an endorsement.