Benign Disease Where Total Hysterectomy is Indicated Clinical Trial
Official title:
Prospective, Multicenter, Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Total Laparoscopic Hysterectomy
This is a prospective, non-randomized, single arm, multicenter, study to assess the initial
clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during
total laparoscopic hysterectomy. The study will not modify or influence current surgeon
technique. Investigators will perform each procedure using the device in compliance with
their standard surgical approach and product labeling.
The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in
accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled,
calibrated, and/or used in accordance with manufacturer design specifications, product
instructions and guidelines
Study Population: Subjects enrolled into this study will undergo elective total laparoscopic
hysterectomy for benign indications wherein dissection and transection of the uterine
vasculature is indicated.
Primary Variable: Incidence of hemostasis at the named vessel/pedicle (UA or UP) on the left
side. Incidence of hemostasis at the named vessel/pedicle (UA or UP) on the right side
Definition: Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or
no). "Yes" is defined as the hemostatic transection of the uterine vasculature (left /
right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle
with the second activation tone heard) without the use of additional hemostatic measures
(i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.)
other than the Harmonic ACE®+7 device.
Note: Multiple applications of the Advanced Hemostasis mode and/or additional applications
of the device in a maximum (MAX) or minimum (MIN) mode are allowed.
Secondary Endpoints:
Incidence of hemostasis at the OP on the left and/or right side If the study procedure also
includes the transection and sealing of one or both OPs, hemostasis of the left and/or right
OP will also be recorded. Hemostasis of the OP is a dichotomous variable (i.e. yes or no).
"Yes" is defined as the hemostatic transection of the ovarian vasculature (left and/or
right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle
with the second activation tone heard) without the use of additional hemostatic measures
(i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.).
Note: Multiple applications of the Advanced Hemostasis mode or the device in a MAX or MIN
mode are allowed.
Incidence of requirement for additional measures to obtain hemostasis on the named
vessel/pedicle (UA or UP and/or OP) on the left and right side Use of other energy devices
(tissue sealers, cautery devices) - Graded as yes or no; if "yes", the name and type, time
of application (24 hour clock).
Use of additional hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) -
Graded as yes or no; if "yes", the name and type, number/volume, and time of application (24
hour clock).
Incidence of complications associated with vaginal cuff healing including dehiscence or
separation, infection, cellulitis, abscess, inflammation, and granulation associated with
each suture used as part of the study.
Adverse events attributed to the study device or procedure will be collected from time of
surgery to Visit 4 (Approximately 4 to 6 weeks after study surgery or as per standard of
care (SOC)).
No formal sample size determination is required for this study. Approximately 40 subjects
from the United States and the European Union are planned to be enrolled into this study.
Global indication for use of the The Harmonic ACE®+7, 5mm Diameter Shears with Advanced
Hemostasis:
Indicated for soft tissue incisions when bleeding control and minimal thermal injury are
desired. The instruments can be used as an adjunct to or substitute for electrosurgery,
lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic,
exposure to orthopedic structures (such as spine and joint space), sealing and transection
of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for
the coagulation of vessels up to and including 7mm in diameter, using the Advanced
Hemostasis function.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment