Benign or Malignant Disease Indicated for Colectomy Clinical Trial
Official title:
Prospective, Multicenter, Observational Study Evaluating Vessel Sealing Utilizing the Harmonic ACE®+7 Shears During Laparoscopic Colectomy
This is a prospective, non-randomized, single arm, multicenter, observational study to
assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel
sealing during laparoscopic colectomy. 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 laparoscopic
colectomy wherein dissection and transection of the (inferior mesenteric artery) IMA is
indicated.
Primary Variable: Incidence of hemostasis at the IMA Secondary Endpoint: Incidence of
hemostasis at the inferior mesenteric vain (IMV).
Definition: Hemostasis of the IMA and IMV is a dichotomous variable (i.e. yes or no). "Yes"
is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the
IMA and IMV.
Incidence of requirement for additional measures to obtain hemostasis on the IMA and/or IMV,
if identified:
- Number of Harmonic touch ups - frequency of Harmonic reapplications required due to
oozing or bleeding at initial transection of named vessels
- Use of other energy devices (tissue sealers, cautery devices) - Graded as yes or no; if
"yes", the type, transection time (using stopwatch), time of application (24 hour
clock)
- Use of hemostatic products (e.g. hemoclips, staples, sutures, fibrin sealants) - Graded
as yes or no; if "yes", the type and name of product, number/volume, and time of
application (24 hour clock)
Incidence of use of additional treatment after first pass hemostasis has already been
achieved at the IMA and IMV. Graded as yes or no; if "yes", the type, number/volume, time of
application (24 hour clock) and rationale for use.
Adverse events attributed to the study device or procedure will be collected from time of
surgery to Visit 4 (Approximately 4 weeks after study surgery or as per standard of care
(SOC)).
Sample size: 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.
;
Observational Model: Case-Only, Time Perspective: Prospective