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A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
N/A
Waitlist Available
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 up to approximately 1 year and 7 months
Awards & highlights
No Placebo-Only Group
Summary
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.
Eligible Conditions
- Gynecological Procedures
- Thoracic Procedures
- Adult Urological Procedures
- Child surgery
- Surgery
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year and 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year and 7 months
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)
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Secondary study objectives
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm)
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 Surgical Procedures (HARMONIC 700 Shears)Experimental Treatment1 Intervention
This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 700 Shears instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery.
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Who is running the clinical trial?
Ethicon Endo-SurgeryLead Sponsor
84 Previous Clinical Trials
35,910 Total Patients Enrolled
Ethicon Endo-Surgery, Inc. Clinical TrialStudy DirectorEthicon Endo-Surgery, Inc.