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

Not Applicable

Completed

• Conditions: The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm
• Interventions: Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel

• Registration Number: NCT06002737
• Lead Sponsor: Hecheng Li M.D., Ph.D

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

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Primary Completion: 2023-12-11
• Study Completion: 2024-04-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel	Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel
Arm 1	Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel	Using Experimental harmonic scalpel to dissect the vessel

Primary Outcome Measures

Name	Time	Method
The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife	From the target Vascular detachment to finish of the surgery	The success rate is defined as the number of subjects who successfully occluded and severed blood vessels divided by the number of subjects in the analysis dataset. Each subject should use an ultrasound knife to occlude and sever at least one target vessel

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China