A Prospective, Single-Arm Multi-Center Study of the HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)
T
Troy Markel, MD
Primary Investigator
Enrolling By Invitation
110 years or below
All
Phase
N/A
25 participants needed
1 Location
Brief description of study
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be recruited from the investigators’ existing patient population who plan to have a procedure from the proposed procedure groups - pediatric surgical procedures (general) and adult surgical procedures (general, gynecological, urological, and thoracic).
Participants recruited for the study will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU). Subjects will be consented and screened anytime during a period of 8 weeks prior to the date of surgery.
Participants recruited for the study will include pediatric participants aged less than (<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU). Subjects will be consented and screened anytime during a period of 8 weeks prior to the date of surgery.
Detailed description of study
What will happen during the study?
- This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (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 IFU.
- All enrolled subjects will be followed post-operatively through discharge and again at 28 days (± 14 days) post-surgery; therefore, from the surgery date to study exit, the duration will be approximately 6 weeks.
- End of study is defined as date of last patient last visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: all, Riley
-
Age: 110 years or below
-
Gender: All
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
Updated on
08 Jan 2025.
Study ID: SURG-ETHICON-HARMONIC-700, 23314
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