Actively Recruiting
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Led by Ethicon Endo-Surgery · Updated on 2026-06-05
165
Participants Needed
9
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the performance and safety of the HARMONIC 700 Shears device when used according to its instructions in both pediatric and adult surgical procedures. The study includes pediatric general surgeries and adult general, gynecological, urological, and thoracic surgeries. It is designed as a prospective, single-arm, multi-center observational study to collect data in a real-world post-market setting. During the study, surgeons will use the HARMONIC 700 Shears device following their standard surgical methods and the device's instructions for use. The study will capture data from these procedures without additional interventions beyond necessary clinical care. Participants include children under 18 undergoing non-emergency surgeries and adults undergoing elective surgeries, with at least one vessel transection performed using the device. Participants will be monitored from the time of surgery through hospital discharge and again about 28 days afterwards. Researchers will assess the success of vessel sealing during surgery and track any device-related adverse events for up to approximately one year and seven months. The main outcomes include the number of vessel transections achieving a certain level of hemostasis and safety events related to the device.
CONDITIONS
Brief Title
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients undergoing non-emergency general surgery where at least one vessel will be cut using the HARMONIC 700 Shears
- Participants under 18 years of age at the time of surgery
- Parent or legal guardian must provide written consent for pediatric participants
- Adult patients scheduled for elective general, gynecological, urological, or thoracic surgery where at least one vessel will be cut using the HARMONIC 700 Shears
You will not qualify if you...
- Physical or psychological conditions that would prevent participation in the study
- Pregnant participants of childbearing potential
- Participation in another interventional clinical study that could affect study results
- Cases where the HARMONIC 700 Shears were not used to cut at least one vessel during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical procedures using the HARMONIC 700 Shears device according to standard surgical practices.
1 surgical procedure visit (in-person)
Duration - Up to approximately 1 month
Participants are followed post-operatively through discharge and again at approximately 28 days after surgery to monitor recovery and any device-related events.
Approximately 2 visits (in-person)
Trial Site Locations
Total: 9 locations
1
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Completed
2
NextStage Clinical Research
Wichita, Kansas, United States, 67214
Withdrawn
3
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Completed
4
The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
Houston, Texas, United States, 77030
Withdrawn
5
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
6
Dorset County Hospital Nhs Foundation Trust
Dorchester, United Kingdom, DT1 2JY
Completed
7
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Completed
8
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
9
Yeovil District Hospital
Yeovil, United Kingdom, BA214AT
Actively Recruiting
Research Team
K
Kristy Canavan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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