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Electrosurgical Device

HARMONIC 1100 Shears for Surgical Procedures

N/A
Waitlist Available
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
No Placebo-Only Group

Summary

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.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Distribution of 5-point scale scores for sealing and transection of lymphatic vessels completed by HARMONIC 1100 Shears

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HARMONIC 1100 Shears
2021
N/A
~270

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.
Effects of a Laxation and Probiotic Bowel Preparation Regimen: A Randomized Controlled Trial in Patients Undergoing Prostate Radiation Therapy.Preservation of intestinal motility after the serial transverse enteroplasty procedure in a large animal model of short bowel syndrome.Low-amplitude propagated contractile waves: a relevant propulsive mechanism of human colon.

Find a Location

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor
84 Previous Clinical Trials
35,810 Total Patients Enrolled
Attila Nakeeb, MDPrincipal InvestigatorIU Health University Hospital
Troy Markel, MDPrincipal InvestigatorRiley Hospital for Children at Indiana University Health
Moishe Liberman, MDPrincipal InvestigatorCentre Hospitalier de l'Universite de Montreal
3 Previous Clinical Trials
400 Total Patients Enrolled
Ethicon Endo-Surgery Clinical TrialStudy DirectorEthicon Endo-Surgery
3 Previous Clinical Trials
347 Total Patients Enrolled

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
~61 spots leftby Dec 2025