Trials Sponsors Conditions Drugs Pricing

Conditions

The Safety of Ultrasound Knife Coagulation for Blood Vessels With a Diameter Greater Than 5mm and Less Than or Equal to 7mm

Outcome Measures

Primary Outcomes (1)

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
From the target Vascular detachment to finish of the surgery

Study Arms (2)

Arm 1

EXPERIMENTAL

Using Experimental harmonic scalpel to dissect the vessel

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

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

Interventions

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.

Arm 1Arm 2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\) 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;

Sponsors & Collaborators

Hecheng Li M.D., Ph.D
Otherlead
Zhejiang University
Othercollaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Sites (1)

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, 200030, China

Related Publications (2)

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.
PMID: 41133002DERIVED
Wang 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.
PMID: 39030560DERIVED

Enrollment

144 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Prof

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 21, 2023

Study Start

August 1, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations