Skip to main content
OpenTrials
Completed

NCT Number: NCT06002737

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) 18 years old ≤ age ≤ 75 years old, regardless of gender;
  • 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;
  • Before the start of the study, the patient is willing and able to sign an informed consent form approved by the ethics committee;
  • 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;
  • Prothrombin time greater than 5 seconds;
  • Researchers have determined that the tumor may invade the target blood vessel, which may affect the operation or effectiveness of vascular occlusion and disconnection;
  • 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;
  • Patients receive preoperative chemotherapy and radiation therapy;
  • Patient's fasting blood glucose ≥ 11.1mmol/l;
  • 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;
  • Pregnant or lactating women, or women with pregnancy plans during the trial period;
  • Participated in other clinical studies within 3 months;
  • Individuals with mental disorders and lack of autonomous behavioral ability;
  • Other researchers believe that it is not suitable to participate in the experiment.

Treatment and study plan

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

Device

Screening of lung or esophageal surgery patients who meet the inclusion criteria but do not meet the exclusion criteria, and evaluating the effectiveness and safety of ultrasound scalpel in the process of coagulation of blood vessels with a diameter greater than 5mm but not equal to 7mm.

Primary outcomes

  1. The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hecheng Li M.D., Ph.D

Other

Collaborators

  • Ruijin Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Zhejiang University

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.