A prospective, multicenter, randomized, single-blind, parallel controlled clinical trial was conducted to evaluate the safety and efficacy of Integrated Ultrasonic & High Frequency Surgical Equipment for soft tissue cutting and vascular closure and hemostasis

A prospective, multicenter, randomized, single-blind, parallel controlled clinical trial was conducted to evaluate the safety and efficacy of Integrated Ultrasonic & High Frequency Surgical Equipment for soft tissue cutting and vascular closure and hemostasis)

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400088694

Enrollment

Unknown

Registered

2024-08-26

Start date

2023-07-08

Completion date

Unknown

Last updated

2024-09-02

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

Conditions

None

Interventions

Test group:Integrated Ultrasonic & High Frequency Surgical Equipment produced by Innolcon Medical

Control group:Ultrasonic Surgical & Electrosurgical Generator and Harmonic HD 1000i Ultrasonic Surgical Devices(Ethicon Endo-Surgery)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-80 years old (inclusive), gender is not limited; (2) Patients who need to perform soft tissue dissection and blood vessel closure hemostasis (including 5mm < diameter =7mm) in thoracic surgery; (3) Voluntarily participate in this clinical trial and sign the subject informed consent.

Exclusion criteria

Exclusion criteria: (1) Platelet count less than 50×109 /L, severe anemia (Hb=60g/L) or active bleeding within 1 month; (2) Patients with abnormal coagulation function (APTT > 1.5 times the upper limit of normal value) have clinical significance; (3) Patients with heart disease (NYHA grade =III, liver and kidney dysfunction (serum creatinine, ALT, AST greater than 2 times the upper limit of normal value), or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction during the screening period; (4) Patients with other systemic diseases, or who cannot tolerate surgery due to local or systemic infections; (5) Pregnant and lactating women; (6) Participants who participated in other interventional clinical trials within 1 month before the start of this trial; (7) Participants considered inappropriate to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
Success rate of incision and vascular closure during surgery;	—

Secondary

Measure	Time frame
Intraoperative blood loss;Postoperative diversion;Operation time;Instrument performance evaluation;Satisfaction with surgical incision and hemostasis;	—

Countries

China

Contacts

Public ContactChen Yongbing

The Second Affiliated Hospital of Soochow University

chentongt@sina.com+86 138 6201 8774

Outcome results

None listed

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