Clinical trial NCT06608485: A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Surgical Procedures
Adult Surgical Procedures
Adult Gynecological Procedures
Adult Urological Procedures
Adult Thoracic Procedures
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 165
Sex: ALL
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.


Eligibility 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

Primary outcomes:
measure: Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
timeFrame: Intraoperative
measure: Number of Participants with Device-Related Adverse Events (AEs)
timeFrame: Up to approximately 1 year and 7 months
Secondary outcomes:
measure: 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)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University Health
state: Indiana
city: Wichita
country: United States
facility: NextStage Clinical Research
state: Kansas
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Houston
country: United States
facility: The Methodist Hospital Research Institute D B A Houston Methodist Research Institute
state: Texas
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital Nhs Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Ethicon Endo-Surgery, Inc.
name: Ethicon Endo-Surgery, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: