Evaluating HARMONIC 700 Shears for Surgical Procedures
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)
Ethicon Endo-Surgery · NCT06608485
This study is testing how safe and effective the HARMONIC 700 Shears are for both kids and adults during planned surgeries where a blood vessel needs to be cut.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 165 (estimated) |
| Ages | N/A to 110 Years |
| Sex | All |
| Sponsor | Ethicon Endo-Surgery (industry) |
| Locations | 9 sites (Indianapolis, Indiana and 8 other locations) |
| Trial ID | NCT06608485 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and performance of the HARMONIC 700 Shears device in both pediatric and adult surgical procedures. It is an observational study that will evaluate the device's effectiveness when used according to its instructions for use during non-emergent and elective surgeries. Participants will include children and adults undergoing procedures where at least one vessel is planned to be transected. The study will gather data on the device's performance in a real-world clinical setting.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients under 18 and adults undergoing elective surgical procedures involving vessel transection.
Not a fit: Patients with physical or psychological conditions that impair participation or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and safety for patients undergoing various surgical procedures.
How similar studies have performed: While this study focuses on a specific device, similar studies evaluating advanced surgical tools have shown promising results in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana and 8 other locations
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States (COMPLETED)
- NextStage Clinical Research — Wichita, Kansas, United States (WITHDRAWN)
- Icahn School of Medicine at Mt. Sinai — New York, New York, United States (COMPLETED)
- The Methodist Hospital Research Institute D B A Houston Methodist Research Institute — Houston, Texas, United States (WITHDRAWN)
- Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (RECRUITING)
- Dorset County Hospital Nhs Foundation Trust — Dorchester, United Kingdom (COMPLETED)
- Western General Hospital — Edinburgh, United Kingdom (COMPLETED)
- Southampton General Hospital — Southampton, United Kingdom (RECRUITING)
- Yeovil District Hospital — Yeovil, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Kristy Canavan
- Email: kcanava2@its.jnj.com
- Phone: 904-443-1474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures, Adult Thoracic Procedures