Clinical trial NCT06002737: The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
Official title: The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Zhejiang University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2023-08-21
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 disconnection and occlusion

Eligibility criteria: 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.

Primary outcomes:
measure: The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife
timeFrame: From the target Vascular detachment to finish of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine Ruijin Hospital
state: Shanghai
Study officials:
References: