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NCT Number: NCT06608485

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

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.

Recruiting

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Key information

Conditions

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

Age range

Up to 110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis

    Time frame: Intraoperative

    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.

  2. Number of Participants with Device-Related Adverse Events (AEs)

    Time frame: Up to approximately 1 year and 7 months

    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.

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)

    Time frame: Intraoperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristy Canavan

CONTACT

[email protected]

904-443-1474

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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