265 Participants Needed

HARMONIC 1100 Shears for Surgical Procedures

Recruiting at 6 trial locations
SC
KC
Overseen ByKristy Canavan
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Ethicon Endo-Surgery
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying the use of HARMONIC 1100 Shears and Generator G11 in surgeries for children and adults. These tools use sound waves to cut tissues and stop bleeding, aiming to make surgeries faster and safer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the HARMONIC 1100 Shears generally safe for use in humans?

The HARMONIC 1100 Shears, part of the Harmonic ultrasonic devices family, have been used in various surgeries for precise cutting and sealing with minimal complications. Studies show they provide good hemostasis (stopping bleeding), minimal heat damage to surrounding tissues, and no risk of electrical current passing to the patient, indicating a strong safety profile.12345

How is the HARMONIC 1100 Shears treatment different from other treatments?

The HARMONIC 1100 Shears is unique because it uses ultrasonic energy to cut and seal tissues, which minimizes heat damage to surrounding areas and reduces smoke during surgery. This device is designed to efficiently seal larger blood vessels up to 7 mm, offering advanced hemostasis (stopping bleeding) compared to traditional surgical tools.13678

What data supports the effectiveness of the HARMONIC 1100 Shears treatment?

Research shows that ultrasonic surgical devices like the HARMONIC Shears are effective in providing excellent hemostasis (stopping bleeding), efficient cutting, and minimal heat damage to surrounding tissues. These devices have been used successfully across various surgical procedures, indicating their broad effectiveness in improving patient outcomes.13479

Who Is on the Research Team?

TM

Troy Markel, MD

Principal Investigator

Riley Hospital for Children at Indiana University Health

ML

Moishe Liberman, MD

Principal Investigator

Centre Hospitalier de l'Universite de Montreal

EE

Ethicon Endo-Surgery Clinical Trial

Principal Investigator

Ethicon Endo-Surgery

AN

Attila Nakeeb, MD

Principal Investigator

IU Health University Hospital

Are You a Good Fit for This Trial?

This trial is for children and adults needing non-emergency laparoscopic surgery where blood vessels are cut using HARMONIC 1100 Shears. Kids must have consent from a guardian, who can also give assent if the child understands the study. Adults must agree to follow the study plan.

Exclusion Criteria

Preoperative: Physical or psychological condition impairing study participation; Pregnant female subjects of childbearing age; Enrollment in a concurrent interventional clinical study that could impact study endpoints. Intraoperative: The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo surgical procedures using the HARMONIC 1100 Shears and Generator G11

1 day
1 visit (in-person)

Follow-up

Participants are monitored for device-related adverse events and hemostasis outcomes

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • HARMONIC 1100 Shears
Trial Overview The study tests how well HARMONIC 1100 Shears work in various surgeries like gastrointestinal, gynecological, liver-related, stomach, chest, and urological procedures in both kids and adults.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ethicon Endo-Surgery

Lead Sponsor

Trials
85
Recruited
36,100+

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

Tissue effects in vessel sealing and transection from an ultrasonic device with more intelligent control of energy delivery. [2022]
Ultrasonic surgical and electrosurgical system (USES) with conventional ultrasonic scalpel (CUS) in gastrectomy: a retrospective cohort study. [2022]
An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes. [2023]
The New HARMONIC ACE®+7 Shears: A Game Changer in Ultrasonic Hemostasis. [2019]
Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. [2006]
Efficacy and safety of ultrasonically activated shears in thyroid surgery. [2022]
Videothoracoscopic excision of mediastinal tumors and cysts using the harmonic scalpel. [2008]
Harmonic long shears further reduce operation time in transanal endoscopic microsurgery. [2021]
Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. [2020]
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