Status:
COMPLETED
The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
Lead Sponsor:
Hecheng Li M.D., Ph.D
Collaborating Sponsors:
Ruijin Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Evaluation of the safety and effectiveness of disposable ultrasound soft tissue cutting and hemostasis equipment for coagulating 5-7mm blood vessels with ultrasound scalpel tips
Detailed Description
Screening lung and esophageal surgery patients who must meet the inclusion/exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of 5-7mm blood vessel di...
Eligibility Criteria
Inclusion
- 1\) 18 years old ≤ age ≤ 75 years old, regardless of gender;
- 2\) Based on the preoperative CT examination results, it is determined that the patient has at least one blood vessel that needs to be coagulated during the surgery, with a diameter greater than 5mm but less than or equal to 7mm;
- 3\) Before the start of the study, the patient is willing and able to sign an informed consent form approved by the ethics committee;
- 4\) The patient understands the clinical study, cooperates with the research procedure, and is willing to conduct postoperative follow-up according to the protocol.
Exclusion
- 1\) Patient body mass index (BMI) ≥ 35.0 kg/m2;
- 2\) Prothrombin time greater than 5 seconds;
- 3\) Researchers have determined that the tumor may invade the target blood vessel, which may affect the operation or effectiveness of vascular occlusion and disconnection;
- 4\) Researchers have determined that there may be variations, deformities, or calcifications in the target vessel that may affect the evaluation of the primary endpoint, which may affect the operation or effectiveness of vascular occlusion and disconnection;
- 5\) Patients receive preoperative chemotherapy and radiation therapy;
- 6\) Patient's fasting blood glucose ≥ 11.1mmol/l;
- 7\) Hypertensive patients' blood pressure has not been effectively controlled, and their blood pressure is ≥ 140/90 millimeter of mercury （mmHg） in a stable state after medication;
- 8\) Pregnant or lactating women, or women with pregnancy plans during the trial period;
- 9\) Participated in other clinical studies within 3 months;
- 10\) Individuals with mental disorders and lack of autonomous behavioral ability;
- 11\) Other researchers believe that it is not suitable to participate in the experiment.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06002737
Start Date
August 1 2023
End Date
April 18 2024
Last Update
May 22 2024
Active Locations (1)
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1
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200030