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Study of HARMONIC 700 Shears in Surgical Procedures

This study is looking at the HARMONIC 700 Shears, a device used in surgery to cut and seal blood vessels. The main goal is to see how well it works and if it's safe when used in children and adults during various surgical procedures, including gynecological, urological, and thoracic surgeries. Researchers will measure how effectively the device stops bleeding during surgery and track any device-related problems for up to about 1 year and 7 months. You may be able to join if you are having a non-emergency surgery where the HARMONIC 700 Shears will be used, and you are between 0 and 110 years old. The study is currently unclear on its recruitment status and plans to include 165 participants.

Study design
This is an observational study, meaning researchers will watch how the HARMONIC 700 Shears are used in real-world surgical settings. It aims to include 165 participants of all ages.
What's involved
There is no intervention beyond necessary clinical care in this study; the HARMONIC 700 Shears will be used as part of your planned surgery. Researchers will assess bleeding during surgery and monitor for device-related issues for up to approximately 1 year and 7 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for device-related adverse events for up to approximately 1 year and 7 months after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06608485

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

Completed
Not specifiedAll AgesObservational
Ethicon Endo-Surgery
~173 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:HARMONIC 700 Shears

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Measured over Intraoperative
+1 more outcome measured

Conditions

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

Explore related trials

Adult Thoracic ProceduresAdult Urological ProceduresGynecological procedurePediatric Surgical ProceduresSurgical Procedure

Where it's being run

7 sites across 4 states
United Kingdom4
Indiana1
New York1
Quebec1

Study leadership

  • Ethicon Endo-Surgery, Inc. Clinical Trial · STUDY_DIRECTOR · Ethicon Endo-Surgery, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Vessel Transections With an Achievement of Grade 3 or Lower HemostasisIntraoperative

    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.

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