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
- Conditions
- None
- Registration Number
- ChiCTR2400088694
- Lead Sponsor
- The Second Affiliated Hospital of Soochow University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
(1) Age 18-80 years old (inclusive), gender is not limited;<br>(2) Patients who need to perform soft tissue dissection and blood vessel closure hemostasis (including 5mm < diameter =7mm) in thoracic surgery;<br>(3) Voluntarily participate in this clinical trial and sign the subject informed consent.
(1) Platelet count less than 50×109 /L, severe anemia (Hb=60g/L) or active bleeding within 1 month;<br>(2) Patients with abnormal coagulation function (APTT > 1.5 times the upper limit of normal value) have clinical significance;<br>(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;<br>(4) Patients with other systemic diseases, or who cannot tolerate surgery due to local or systemic infections;<br>(5) Pregnant and lactating women;<br>(6) Participants who participated in other interventional clinical trials within 1 month before the start of this trial;<br>(7) Participants considered inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of incision and vascular closure during surgery;
- Secondary Outcome Measures
Name Time Method Intraoperative blood loss;Postoperative diversion;Operation time;Instrument performance evaluation;Satisfaction with surgical incision and hemostasis;