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A prospective, multicenter, randomized, open-label, parallel-controlled, non-inferiority trial to evaluate the clinical efficacy and safety of the ultrasonic scalpel hemostasis system.

A prospective, multicenter, randomized, open-label, parallel-controlled, non-inferiority trial to evaluate the clinical efficacy and safety of the ultrasonic scalpel hemostasis system.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108774
Enrollment
Unknown
Registered
2025-09-04
Start date
2020-12-10
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental Group:During the operation, the ultrasonic cutting hemostasis knife system was used for soft tissue cutting and hemostasis.
Control group:During the operation, the already market-available ultrasonic high-frequency surgical integrated surgical equipment was used for soft tissue cutting and hemostasis.

Sponsors

The Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The subjects voluntarily participated in the trial and signed the informed consent form. (2) Age range: 18 - 75 years old. Gender not restricted. (3) Patients who need to undergo open surgery or endoscopic surgery using the ultrasound cutting hemostasis knife system. (4) Patients who can communicate well with the researchers and comply with the trial requirements.

Exclusion criteria

Exclusion criteria: (1) Patients with severe heart, liver, kidney, and blood system diseases, as well as severe metabolic disorders (2) Patients requiring ultrasonic knife to close blood vessels with a measured diameter greater than 3mm (3) Patients whose overall condition cannot withstand surgery (4) Patients with systemic infections such as sepsis or bacteremia (5) Patients requiring cutting surgeries on bone tissues and central nervous tissues of the brain and spinal cord (6) Patients requiring tubal ligation surgery (7) Patients with a history of alcohol or drug abuse in the past 6 months (8) Pregnant, lactating, or women with pregnancy plans (9) Patients with mental disorders or those who cannot cooperate with surgical treatment (10) Patients allergic to the test-related equipment or materials, or who have had severe allergic reactions recently (11) Patients who participated in other clinical trials within 3 months before the screening period (12) Other researchers consider not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
Overall performance excellence rate;

Secondary

MeasureTime frame
Surgical situation;Equipment performance evaluation;Success rate of operation;Postoperative drainage situation;

Countries

China

Contacts

Public ContactWang Weilin

The Second Affiliated Hospital of Zhejiang University School of Medicine

wam@zju.edu.cn+86 136 0664 2087

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026