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A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

NCT05039021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2025-04-30

Study results available
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Summary

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (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 1100 Shears and Generator G11 instructions for use.

Conditions

  • Pediatric Procedures
  • Adult Hepato-pancreato-biliary (HPB) Procedures
  • Adult Lower Gastrointestinal Procedures
  • Adult Gastric Procedures
  • Adult Gynecological Procedures
  • Adult Urological Procedures
  • Adult Thoracic Procedures

Interventions

DEVICE

HARMONIC 1100 Shears

HARMONIC 1100 Shears is used for vessel transection according to instructions for use.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Ethicon Endo-Surgery Clinical Trial · Ethicon Endo-Surgery

  • Troy Markel, MD · Riley Hospital for Children at Indiana University Health

  • Attila Nakeeb, MD · IU Health University Hospital

  • Moishe Liberman, MD · Centre Hospitalier de l'Universite de Montreal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2024-02-04
Completion
2024-03-12
FDA Device
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05039021 on ClinicalTrials.gov