The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mmNCT06002737
The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
A study testing Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel in people with The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm, run by Hecheng Li M.D., Ph.D at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm
- What is being tested?
- Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200030
About this study
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
Read the 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
- Being tested
- Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Using Experimental harmonic scalpel to dissect the vessel Receives: 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 | Using Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel Receives: Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of successful coagulation and disconnection of target blood vessels using ultrasound knife
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
Measured: From the target Vascular detachment to finish of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Aug 2023
- Primary completion11 Dec 2023
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hecheng Li M.D., Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor-investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002737
- Sponsor's protocol ID
- RTS-018
- Status last verified
- May 2024
- First submitted
- 16 Aug 2023
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Li C, Niu Z, Xu J, Yao J, Yan Y, Chang Z, Wang X, Jing H, Han D, Zhang Y, Che J, Lin J, Wang M, Fan J, Hu J, Li H. Evaluation of ultrasonic energy for sealing 5-7 mm blood vessels in thoracoscopic surgery: a noninferiority randomized controlled trial. Transl Lung Cancer Res. 2025 Sep 30;14(9):3636-3644. doi: 10.21037/tlcr-2025-433. Epub 2025 Sep 25.
PubMed 41133002Wang X, Li C, Fan J, Hu J, Wang M, Li H. Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. BMC Surg. 2024 Jul 19;24(1):212. doi: 10.1186/s12893-024-02497-x.
PubMed 39030560
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Using Ultrasound Scalpel to Coagulate 5-7mm Blood Vessels : a Prospective, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06002737
- Acronym / sponsor ID
- RTS-018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hecheng Li M.D., Ph.DUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpelUsing Experimental harmonic scalpel to dissect the vessel |
| Arm 2 | Active comparator | Device: Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpelUsing Harmonic Ace+7(Ethicon Endo-Surgery, LL), 5mm Diameter Shears with Advanced Hemostasis to dissect the vessel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpelScreening 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. | Device | Arm 1, Arm 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 41133002Li C, Niu Z, Xu J, Yao J, Yan Y, Chang Z, Wang X, Jing H, Han D, Zhang Y, Che J, Lin J, Wang M, Fan J, Hu J, Li H. Evaluation of ultrasonic energy for sealing 5-7 mm blood vessels in thoracoscopic surgery: a noninferiority randomized controlled trial. Transl Lung Cancer Res. 2025 Sep 30;14(9):3636-3644. doi: 10.21037/tlcr-2025-433. Epub 2025 Sep 25.
- Derived from this study: PubMed 39030560Wang X, Li C, Fan J, Hu J, Wang M, Li H. Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. BMC Surg. 2024 Jul 19;24(1):212. doi: 10.1186/s12893-024-02497-x.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusion of blood vessels with a diameter greater than 5mm and less than or equal to 7mm using harmonic scalpel in people with The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm, run by Hecheng Li M.D., Ph.D at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002737, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.