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

NCT06608485 | Completed FDA Device

• 1 other identifier: ENG202301
• Study Type: observational
• Target: 173
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Adult Urological Procedures; Pediatric Surgical Procedures; Adult Thoracic Procedures; Adult Surgical Procedures; Adult Gynecological Procedures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

  Intraoperative

Study Arms (1)

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

Interventions

HARMONIC 700 Shears DEVICE

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

Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears)

Eligibility Criteria

• Age: Up to 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (7)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

Dorset County Hospital Nhs Foundation Trust

Dorchester, DT1 2JY, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Yeovil District Hospital

Yeovil, BA214AT, United Kingdom

Location

Study Officials

• Ethicon Endo-Surgery, Inc. Clinical Trial

  Ethicon Endo-Surgery, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: January 23, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1); GB (4)