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

Ethicon Endo-Surgery165 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Pediatric Surgical Procedures Adult Surgical Procedures Adult Gynecological Procedures Adult Urological Procedures Adult Thoracic Procedures

Interventions

There is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.

Eligibility

Sex: ALLMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (9)

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WITHDRAWN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WITHDRAWN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

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis

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.

Time frame: Intraoperative

Number of Participants with Device-Related Adverse Events (AEs)

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.

Time frame: Up to approximately 1 year and 7 months

Secondary Outcomes

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)

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.

Time frame: Intraoperative

Central Contacts

Kristy Canavan

CONTACT

904-443-1474 kcanava2@its.jnj.com

Data from ClinicalTrials.gov

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