Clinical trial · Interventional
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
NCT07235553CI-TRIAL-00097521completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HARMONIC System | Device | — | UNRESOLVED |
| Ultrasonic Surgical System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasonic Surgical System
- description
- Ultrasonic Surgical System : ES01; single use shear: SHC23A, SHC36A; handpiece: eHP01
- interventionNames
- Device: Ultrasonic Surgical System
- type
- ACTIVE_COMPARATOR
- label
- HARMONIC System
- description
- HARMONIC System: GEN04; single use shear: ACE23E, ACE36E; handpiece: HP054
- interventionNames
- Device: HARMONIC System
Primary outcomes (1)
- measure
- The overall excellent performance rate
- timeFrame
- during the surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.