HARMONIC 1100 Shears for Surgical Procedures

No longer recruiting at 6 trial locations

Overseen By Kristy Canavan

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ethicon Endo-Surgery

Disqualifiers: Pregnancy, Psychological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather data on the use of HARMONIC 1100 Shears, a surgical tool, during various surgeries. It is designed for both children and adults undergoing planned (non-emergency) surgeries that require cutting blood vessels. The tool is suitable for adults having general, gynecological, urological, or thoracic surgeries. Participants must agree to follow study rules and provide consent. This trial provides an opportunity to observe the device's performance in real-world surgical settings. As an unphased study, it allows participants to contribute to valuable research that can improve surgical outcomes.

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.

What prior data suggests that the HARMONIC 1100 Shears is safe for surgical procedures?

Research has shown that HARMONIC 1100 Shears are safe for use. Studies indicate that these shears effectively control bleeding during surgery and cause minimal heat damage to nearby tissues, reducing the risk of harming healthy areas. Importantly, they pose no risk of electrical current passing through the patient, minimizing the chance of accidental injury from the device. Overall, these shears are well-tolerated and reliable for various surgical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HARMONIC 1100 Shears are unique because they use ultrasonic vibration to cut and coagulate tissue simultaneously, which can reduce bleeding during surgery. Unlike traditional surgical tools that might rely on heat or mechanical cutting alone, the HARMONIC Shears offer more precise and controlled cutting with less thermal spread. This means potentially quicker recovery times and less tissue damage for patients undergoing various procedures, from gastrointestinal to thoracic surgeries. Researchers are excited about these shears because they could enhance surgical efficiency and patient outcomes compared to standard tools.

What evidence suggests that the HARMONIC 1100 Shears is effective for surgical procedures?

Research has shown that the HARMONIC 1100 Shears, used by participants in this trial, effectively stop bleeding during surgeries. Studies indicate that these shears cut tissue faster than other devices. Preclinical studies suggest they cause less heat damage to nearby tissues, making them a reliable tool for various surgeries in both children and adults. The effectiveness of Harmonic devices has been observed in procedures such as kidney removal and minimally invasive uterus removal. ^{1 3 4 5 6}

Who Is on the Research Team?

Moishe Liberman, MD

Principal Investigator

Centre Hospitalier de l'Universite de Montreal

Ethicon Endo-Surgery Clinical Trial

Principal Investigator

Ethicon Endo-Surgery

Troy Markel, MD

Principal Investigator

Riley Hospital for Children at Indiana University Health

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?

Group I: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic) Experimental Treatment 1 Intervention

Any pediatric or adult (hepato-pancreato-biliary, lower gastrointestinal, gastric, gynecological, urological, thoracic) procedures where the HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

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

1. jnjmedtech.com jnjmedtech.com/system/files/pdf/HARMONIC-1100-Shears-VAC-Pack-158953-221102.pdf

HARMONIC® 1100 Shears Based on preclinical studies demonstrating decreased activation times and thermal damage vs. HARMONIC ACE® without Adaptive Tissue Technology.

2. jnjmedtech.com jnjmedtech.com/system/files/pdf/Harmonic-1100-Shears-Vac-pack-259948-231012.pdf

Value Analysis Summary Designed for open and laparoscopic procedures, the HARMONIC™ 1100 Shears provides: ... HARMONIC™ 1100 Shears had transection speeds statistically faster than ...

3. scivisionpub.com scivisionpub.com/pdfs/efficacy-and-usability-of-an-ultrasonic-sealing-device-in-the-pediatric-and-adult-population-a-prospective-evaluation-3595.pdf

Efficacy and Usability of an Ultrasonic Sealing Device in the ... The effectiveness of Harmonic devices have been demonstrated in a wide range of procedures including nephrectomy, laparoscopic hysterectomy,.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/21/NCT05039021/Prot_000.pdf

NCT05039021 Subjects will be considered enrolled when the HARMONIC 1100 Shears has been attempted to be used for at least one single vessel transection ...

5. withpower.com withpower.com/trial/phase-8-2021-7bda4

HARMONIC 1100 Shears for Surgical Procedures Research shows that ultrasonic surgical devices like the HARMONIC Shears are effective in providing excellent hemostasis (stopping bleeding), efficient cutting, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200841.pdf

May 11, 2020 Ethicon Endo-Surgery, LLC Brian Godwin ... The HARMONIC 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The ...