HARMONIC 1100 Shears for Surgical Procedures

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

265 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

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. ^{1 2 4 8 9}

Research Team

Troy Markel, MD

Principal Investigator

Riley Hospital for Children at Indiana University Health

Moishe Liberman, MD

Principal Investigator

Centre Hospitalier de l'Universite de Montreal

Ethicon Endo-Surgery Clinical Trial

Principal Investigator

Ethicon Endo-Surgery

Attila Nakeeb, MD

Principal Investigator

IU Health University Hospital

Eligibility Criteria

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.

Inclusion Criteria

Pediatric population: Primary laparoscopic non-emergent procedure where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU; Less than 18 years of age at the time of procedure; The subject's parent/legal guardian must provide written informed consent and assent must be obtained from pediatric subjects with the ability to comprehend the study. Adult population: Primary laparoscopic elective procedure where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU; Willingness to give consent and comply with study-related evaluations and visit schedule; At least 18 years of age.

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

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)

Treatment Details

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.

Participant Groups

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

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Tissue effects in vessel sealing and transection from an ultrasonic device with more intelligent control of energy delivery. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ultrasonic surgical and electrosurgical system (USES) with conventional ultrasonic scalpel (CUS) in gastrectomy: a retrospective cohort study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

An umbrella review of the surgical performance of Harmonic ultrasonic devices and impact on patient outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The New HARMONIC ACE®+7 Shears: A Game Changer in Ultrasonic Hemostasis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ultrasonically activated shears in thyroid surgery. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Videothoracoscopic excision of mediastinal tumors and cysts using the harmonic scalpel. [2008]

8. Germany pubmed.ncbi.nlm.nih.gov

Harmonic long shears further reduce operation time in transanal endoscopic microsurgery. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Large-Vessel Sealing in Laparoscopic Colectomy with an Ultrasonic Device. [2020]