Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ENG202301 | Other Identifier | Ethicon Endo-Surgery |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears) | This prospective study will involve collection of clinical data in a post-market setting from pediatric surgical procedures (general) and adult surgical procedures (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 instruction for use (IFU). All subjects enrolled will be followed post-operatively through discharge and again at approximately 28 days post-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARMONIC 700 Shears | Device | There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis | 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. | Intraoperative |
| Number of Participants with Device-Related Adverse Events (AEs) | 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. | Up to approximately 1 year and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
Not provided
Inclusion Criteria:
Pediatric participants
Exclusion Criteria:
Preoperative
Not provided
Not provided
Not provided
The study population 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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristy Canavan | Contact | 904-443-1474 | kcanava2@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Ethicon Endo-Surgery, Inc. Clinical Trial | Ethicon Endo-Surgery, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at Indiana University Health | Completed | Indianapolis | Indiana | 46202 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intraoperative |
| NextStage Clinical Research |
| Withdrawn |
| Wichita |
| Kansas |
| 67214 |
| United States |
| Icahn School of Medicine at Mt. Sinai | Completed | New York | New York | 10029 | United States |
| The Methodist Hospital Research Institute D B A Houston Methodist Research Institute | Withdrawn | Houston | Texas | 77030 | United States |
| Centre Hospitalier de l'Universite de Montreal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
| Dorset County Hospital Nhs Foundation Trust | Completed | Dorchester | DT1 2JY | United Kingdom |
| Western General Hospital | Completed | Edinburgh | EH4 2XU | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | SO16 6YD | United Kingdom |
| Yeovil District Hospital | Recruiting | Yeovil | BA214AT | United Kingdom |