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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
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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