A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Completed
Conditions studied: Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures
In brief
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.
Key facts
- Study ID
- NCT06608485
- Run by
- Ethicon Endo-Surgery
- People needed
- 173
- Starts
- 2025-01-23
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-08-03
Who can join
Age: any, up to 110. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
- Icahn School of Medicine at Mt. Sinai — New York, New York, 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
- Yeovil District Hospital — Yeovil, United Kingdom
Full record on ClinicalTrials.gov
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