The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial

Hecheng Li M.D., Ph.D

Status: Completed

Conditions: The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm

Treatments: Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT06002737

RTS-018

Details and patient eligibility

About

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

Full 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 disconnection and occlusion

Enrollment: 144 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Arm 1

Experimental group

Description:

Using Experimental harmonic scalpel to dissect the vessel

Treatment:

Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel

Arm 2

Active Comparator group

Description:

Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel

Treatment:

Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel