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.

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

Adult Thoracic Procedures

Thoracic Procedure

Orthopaedics and surgery

Pediatric Surgical Procedures

Pediatric Procedures

Adult Gynecological Procedures

Adult Urological Procedures

Urologic Procedure

Adult Surgical Procedures

HARMONIC 700 Shears

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)

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.

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.

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.

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.

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status