Adult Gynecological Procedures, Adult Surgical Procedures, Adult Thoracic Procedures, Adult Urological Procedures, Pediatric Surgical Procedures
Conditions
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 and adult surgical procedures.
Interventions
DEVICEHARMONIC 700 Shears
There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.
Sponsors
Ethicon Endo-Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis | Intraoperative | Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example \[e.g.\], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures. |
| Number of Participants with Device-Related Adverse Events (AEs) | Up to approximately 1 year and 7 months | An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm) | Intraoperative | Number of vessel transections with achievement of Grade 3 or lower hemostasis for each vessel transection of diameter \> 5 to 7 mm will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures. |
Countries
Canada, United Kingdom, United States
Contacts
STUDY_DIRECTOREthicon Endo-Surgery, Inc. Clinical Trial
Ethicon Endo-Surgery, Inc.
Outcome results
None listed