A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Pr
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.
| Condition(s) | Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 | 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 im |
| Ages | 110 Years |
| Sex | All |
| Lead sponsor | Ethicon Endo-Surgery |
| Locations | Indianapolis, Indiana, United States; Wichita, Kansas, United States; New York, New York, United States; Houston, Texas, United States; Montreal, Quebec, Canada; Dorchester, United Kingdom (+3 more sites) |
| Start date | 2025-01-23 |
| NCT ID | NCT06608485 |
| Official listing | https://clinicaltrials.gov/study/NCT06608485 |