A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures (NCT06608485) | Clinical Trial Compass
RecruitingNot Applicable
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
United States, Canada165 participantsStarted 2025-01-23
Plain-language 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 and adult surgical procedures.
Who can participate
Age range110 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Timeframe: Intraoperative
2
Number of Participants with Device-Related Adverse Events (AEs)
Timeframe: Up to approximately 1 year and 7 months