Phase
Condition
N/ATreatment
HARMONIC 1100 Shears
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pediatric population:
Non-emergent procedure (general) where at least one vessel is planned to betransected by the HARMONIC 1100 Shears per the IFU;
Less than 18 years of age at the time of procedure; and
The subject's parent/legal guardian must be willing to give permission for thesubject to participate in the study and provide written informed consent for thesubject. In addition, assent must be obtained from pediatric subjects who possessthe intellectual and emotional ability to comprehend the concepts involved in thestudy. If the pediatric subject is not able to provide assent (due to age, maturityand/or inability to intellectually and/or emotionally comprehend the study), theparent/legal guardian's written informed consent for the subject will be acceptablefor the subject to be included in the study.
Adult population:
Elective procedure (general, gynecological, urological, or thoracic) where at leastone vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU;
Willingness to give consent and comply with all study-related evaluations and visitschedule; and
At least 18 years of age.
Exclusion
Exclusion Criteria:
Preoperative
Physical or psychological condition which would impair study participation;
Female subjects, of childbearing age, who are pregnant; or
Enrollment in a concurrent interventional clinical study that could impact the studyendpoints.
Intraoperative
- The HARMONIC 1100 Shears were not attempted to be used for at least one singlevessel transection during the surgical procedure.
Study Design
Connect with a study center
Centre Hospitalier de l'Universite de Montreal
Montreal,
CanadaSite Not Available
Toronto General Hospital
Toronto,
CanadaSite Not Available
Western General Hospital
Edinburgh, Scotland
United KingdomSite Not Available
Baptist Health
Jacksonville, Florida 32207
United StatesSite Not Available
IU Health University Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana 46202
United StatesSite Not Available
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