A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

A Prospective, Single-Arm Multi-Center Study of the HARMONIC™ 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

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.

Study Overview

• Status: Recruiting
• Conditions: Adult Gynecological Procedures; Adult Urological Procedures; Adult Thoracic Procedures; Pediatric Surgical Procedures; Adult Surgical Procedures
• Intervention / Treatment: Device: HARMONIC 700 Shears

• Study Type: Observational
• Enrollment (Estimated): 165

Contacts and Locations

• Study Contact: Name: Kristy Canavan; Phone Number: 904-443-1474; Email: kcanava2@its.jnj.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
• United Kingdom
  • Dorchester, United Kingdom, DT1 2JY
    • Completed
    • Dorset County Hospital NHS Foundation Trust
  • Edinburgh, United Kingdom, EH4 2XU
    • Completed
    • Western General Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital
  • Yeovil, United Kingdom, BA214AT
    • Recruiting
    • Yeovil District Hospital
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Completed
      • Riley Hospital for Children at Indiana University Health
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Withdrawn
      • NextStage Clinical Research
  • New York
    • New York, New York, United States, 10029
      • Completed
      • Icahn School of Medicine at Mt. Sinai
  • Texas
    • Houston, Texas, United States, 77030
      • Withdrawn
      • The Methodist Hospital Research Institute D B A Houston Methodist Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).

Description

Inclusion Criteria:

Pediatric participants

• Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
• Less than 18 years of age at the time of procedure
• Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
• Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
• Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

Exclusion Criteria:

Preoperative

• Physical or psychological condition which would impair study participation
• Participants of childbearing potential who are pregnant
• Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
• HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears); 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.

Device: HARMONIC 700 Shears; There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis	Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example [e.g.], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.	Intraoperative
Number of Participants with Device-Related Adverse Events (AEs)	An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.	Up to approximately 1 year and 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Number of vessel transections with achievement of Grade 3 or lower hemostasis for each vessel transection of diameter > 5 to 7 mm will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.	Intraoperative

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Study Director: Ethicon Endo-Surgery, Inc. Clinical Trial, Ethicon Endo-Surgery, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ENG202301 (Other Identifier: Ethicon Endo-Surgery)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes