A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
NCT ID: NCT06608485
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
165 participants
OBSERVATIONAL
2025-01-23
2026-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
110 Years
ALL
No
Sponsors
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Ethicon Endo-Surgery
INDUSTRY
Responsible Party
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Principal Investigators
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Ethicon Endo-Surgery, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Ethicon Endo-Surgery, Inc.
Locations
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Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
NextStage Clinical Research
Wichita, Kansas, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Houston, Texas, United States
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Dorset County Hospital Nhs Foundation Trust
Dorchester, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ENG202301
Identifier Type: OTHER
Identifier Source: secondary_id
ENG202301
Identifier Type: -
Identifier Source: org_study_id