What side effects are associated with this type of intervention?

Common treatments for lower gastrointestinal procedures using ultrasonic energy, such as the HARMONIC 1100 Shears and Generator G11, typically involve cutting and coagulating tissue. Known side effects of these treatments can include thermal injury to surrounding tissues, inadvertent damage to adjacent organs, bleeding, infection, and postoperative pain. These side effects are generally consistent with those observed in other surgical procedures involving energy-based devices.

What prior FDA approvals exist?

The FDA has approved various devices and drugs for lower gastrointestinal procedures, including those that utilize advanced technologies like ultrasonic energy for cutting and coagulating tissue. One such example is the HARMONIC 1100 Shears and Generator G11, which are used in both pediatric and adult populations for general, gynecological, urological, and thoracic surgical procedures. These devices are designed to enhance precision and reduce thermal damage to surrounding tissues, making them suitable for delicate surgical interventions in the lower gastrointestinal tract.

What other types of research exist?

Promising alternatives to the HARMONIC 1100 Shears and Generator G11 for lower gastrointestinal procedures include robotic-assisted surgery and advanced laparoscopic systems. These technologies offer precision, reduced recovery times, and potentially better outcomes. Specifically, robotic-assisted laparoscopic surgery has shown advantages in terms of reduced conversion rates to open surgery and improved functional outcomes post-surgery.

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Electrosurgical Device

HARMONIC 1100 Shears for Surgical Procedures

N/A

Recruiting

Led By Attila Nakeeb, MD

Research Sponsored by Ethicon Endo-Surgery

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative

Awards & highlights

Study Summary

This trial will collect data on the use of the HARMONIC 1100 Shears in children and adults undergoing various surgical procedures.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, they may include typical surgical risks such as bleeding or infection at the incision site related to using these specialized shears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Device-related Adverse Events (AEs)

The number of vessel transections with an achievement of Grade 3 or lower for each vessel transection based on the scale described below

Secondary outcome measures

Distribution of 5-point scale scores for sealing and transection of lymphatic vessels completed by HARMONIC 1100 Shears

The distribution of grades (1-4) seen from the use of the hemostasis grading scale ( measure) for each vessel transected will be calculated

The number of any additional hemostasis measures required to achieve hemostasis for any Grade 4 vessel transections will be collected

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)Experimental Treatment1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The HARMONIC 1100 Shears and Generator G11 utilize ultrasonic energy to cut and coagulate tissue simultaneously, which is essential for lower gastrointestinal procedures. This dual action reduces intraoperative bleeding and minimizes thermal damage to surrounding tissues, leading to shorter operative times and potentially faster recovery. For patients, this means fewer complications, reduced blood loss, and a quicker return to normal activities, making these devices highly beneficial in achieving optimal surgical outcomes.

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Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor

83 Previous Clinical Trials

35,645 Total Patients Enrolled

Attila Nakeeb, MDPrincipal InvestigatorIU Health University Hospital

Troy Markel, MDPrincipal InvestigatorRiley Hospital for Children at Indiana University Health

Media Library

HARMONIC 1100 Shears (Electrosurgical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05039021 — N/A

Lower Gastrointestinal Procedures Research Study Groups: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)

Lower Gastrointestinal Procedures Clinical Trial 2023: HARMONIC 1100 Shears Highlights & Side Effects. Trial Name: NCT05039021 — N/A

HARMONIC 1100 Shears (Electrosurgical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039021 — N/A

~44 spots leftby May 2025

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