The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Jiao Tong University School of Medicine Ruijin Hospital
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Contact:
- Hecheng Li, MD/PHD
- Phone Number: 021-64370045
- Email: lhc11863@rjh.com.cn
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Contact:
- Chengqiang Li, MD/PHD
- Phone Number: 13524282905
- Email: lcq12305@rjh.com.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Using Experimental harmonic scalpel to dissect the vessel
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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.
|
|
Active Comparator: Arm 2
Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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From the target Vascular detachment to finish of the surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RTS-018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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