Status:
RECRUITING
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Pediatric Surgical Procedures
Adult Surgical Procedures
Eligibility:
All Genders
Up to 110 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06608485
Start Date
January 23 2025
End Date
August 15 2026
Last Update
December 5 2025
Active Locations (8)
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1
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
2
NextStage Clinical Research
Wichita, Kansas, United States, 67214
3
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
4
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Houston, Texas, United States, 77030