HARMONIC 1100 Shears for Adult Lower Gastrointestinal Procedures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Adult Lower Gastrointestinal Procedures+6 MoreHARMONIC 1100 Shears - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Adult Lower Gastrointestinal Procedures
  • Adult Hepato-Pancreato-Biliary Procedures
  • Adult Gastric Procedures
  • Adult Gynecological Procedures
  • Pediatric Procedures
  • Adult Thoracic Procedures
  • Adult Urological Procedures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Intraoperative

Week 6
Number of Participants with Device-related Adverse Events (AEs)
Intraoperative
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
The number of vessel transections with an achievement of Grade 3 or lower for each vessel transection based on the scale described below

Trial Safety

Trial Design

1 Treatment Group

Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urologica...
1 of 1

Experimental Treatment

165 Total Participants · 1 Treatment Group

Primary Treatment: HARMONIC 1100 Shears · No Placebo Group · N/A

Pediatric; adult (HPB, lower gastrointestinal, gastric, gynecological, urological, thoracic)
Device
Experimental Group · 1 Intervention: HARMONIC 1100 Shears · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor
83 Previous Clinical Trials
35,841 Total Patients Enrolled
Attila Nakeeb, MDPrincipal InvestigatorIU Health University Hospital
Moishe Liberman, MDPrincipal InvestigatorCentre Hospitalier de l'Universite de Montreal
Troy Markel, MDPrincipal InvestigatorRiley Hospital for Children at Indiana University Health
Ethicon Endo-Surgery Clinical TrialStudy DirectorEthicon Endo-Surgery
3 Previous Clinical Trials
477 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The procedure is a laparoscopic procedure that requires the use of the HARMONIC 1100 Shears.
You are under 18 years of age.
You are at least 18 years of age.
You are willing to give informed consent and comply with all study-related evaluations and visit schedule.