HARMONIC 700 Shears for Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the HARMONIC 700 Shears, a device used in surgeries to cut and seal blood vessels. Researchers aim to evaluate its effectiveness and safety in both children and adults during various surgeries, such as general, gynecological, and thoracic procedures. It suits those undergoing planned surgeries where a vessel will be cut using this device. Participants will be monitored after surgery to assess their recovery. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to help introduce a potentially effective surgical tool to wider use.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the HARMONIC 700 Shears device is safe for pediatric and adult surgical procedures?
Research has shown that the HARMONIC 700 Shears are generally safe for use in surgeries. Studies have found that this tool effectively cuts and seals tissues with minimal bleeding, reducing complications during operations. Patients in past studies handled the device well, with no major problems reported. The HARMONIC 700 Shears have already received approval for use, which boosts confidence in their safety. While all surgical tools carry some risks, existing evidence supports the safety of this device for both children and adults in surgery.12345
Why are researchers excited about this trial?
Researchers are excited about the HARMONIC 700 Shears because they offer advanced hemostasis—a fancy way of saying they help control bleeding more effectively during surgery. Unlike traditional surgical tools, these shears use ultrasonic energy to precisely cut and coagulate tissue, which can reduce bleeding and improve surgical outcomes. This can be especially beneficial in both pediatric and adult surgeries, where minimizing blood loss and speeding up recovery are crucial. By potentially enhancing surgical precision and safety, the HARMONIC 700 Shears represent a promising advancement in surgical technology.
What evidence suggests that the HARMONIC 700 Shears device is effective for surgical procedures?
This trial will evaluate the use of the HARMONIC 700 Shears in pediatric and adult surgical procedures. Studies have shown that the HARMONIC 700 Shears with Advanced Hemostasis improve surgery outcomes by reducing surgery time and bleeding. Research indicates that patients experience less pain and shorter hospital stays with this device. The device effectively seals blood vessels, controlling bleeding and limiting heat damage to nearby tissues. Reviews of similar Harmonic devices have highlighted benefits such as reduced drainage and improved overall recovery. This evidence supports the effectiveness of the HARMONIC 700 Shears in surgeries for both children and adults.12346
Who Is on the Research Team?
Ethicon Endo-Surgery, Inc. Clinical Trial
Principal Investigator
Ethicon Endo-Surgery, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo surgical procedures using the HARMONIC 700 Shears device
Post-operative Follow-up
Participants are monitored post-operatively through discharge and again at approximately 28 days post-surgery
Extended Follow-up
Participants are monitored for device-related adverse events
What Are the Treatments Tested in This Trial?
Interventions
- HARMONIC 700 Shears
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ethicon Endo-Surgery
Lead Sponsor
Kevin Lobo
Ethicon Endo-Surgery
Chief Executive Officer since 2012
MBA from McGill University
Dr. Afable
Ethicon Endo-Surgery
Chief Medical Officer since 2005
MD from Loyola Stritch School of Medicine
Citations
1.
research-studies.allinforhealth.info
research-studies.allinforhealth.info/us/en/listing/12845/a-prospective-single-arm-multi-center-2/A Prospective, Single-Arm Multi-Center Study of the HARMONIC
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-harmonic-700-shears-with-advanced-hemostasis-in-pediatric-and-adult-surgical-proceduresA Study of HARMONIC 700 Shears With Advanced ...
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market ...
HARMONIC™ 700 with Advanced Hemostasis | Ethicon
The HARMONIC 700 Shears is an advanced energy, ultrasonic device that is a sterile, single patient use instrument used for general dissection, vessel sealing, ...
February 28, 2023 Ethicon Endo-Surgery, LLC Hillary Lewis ...
The HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are intended for soft tissue incisions when bleeding control and minimal thermal ...
An umbrella review of the surgical performance of Harmonic ...
Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall ...
A Prospective, Single-Arm Multi-Center ...
A Prospective, Single-Arm Multi-Center Study of the HARMONIC[TM] 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.