A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

Recruiting

• Conditions: Pediatric Surgical Procedures; Adult Surgical Procedures; Adult Gynecological Procedures; Adult Urological Procedures; Adult Thoracic Procedures
• Interventions: Device: HARMONIC 700 Shears

• Registration Number: NCT06608485
• Lead Sponsor: Ethicon Endo-Surgery

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2025-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-05-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric; Adult Surgical Procedures (HARMONIC 700 Shears)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Riley Hospital for Children at Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

NextStage Clinical Research; 🇺🇸 Wichita, Kansas, United States

Icahn School of Medicine at Mt. Sinai; 🇺🇸 New York, New York, United States

The Methodist Hospital Research Institute D B A Houston Methodist Research Institute; 🇺🇸 Houston, Texas, United States

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Dorset County Hospital Nhs Foundation Trust; 🇬🇧 Dorchester, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom