Evaluation of Efficacy and Accuracy of a Cordless Ultrasonic Dissection System

The Sonicision device offers the ability to achieve hemostasis and vessel dissection with a
cordless system. The ultrasonic device yields coagulation and transection of vessels by
conversion of electrical energy into ultrasonic vibration through a piezoelectric or
magnetic transducer, which is the causation of heat induction at the jaws of the instrument
through friction. The Sonicision device is able to seal vessels up to 5 mm and transection
division of 10 cm segments. The Sonicision device features the following:

1. Cordless design to improve freedom and movement;

2. Simplified set up that may possibly increase operating room efficiency;

3. Dual-mode energy control to increase procedure focus;

4. Improved mobility secondary to cordless system.

Currently all devices are connected to a generator by a cable, which can lead to the cable
wrapping around the device, tangle with other instruments and become inadvertently
contaminated. There are several advantages with regards to utilization of a cordless device
to include: improved intra-operative storage, avoidance of bundling multiple cords from
various instruments that may limit instrument mobility and portability which may lead to the
ability to operate with advanced surgical equipment in third world settings, trauma and
surgery centers.

The study group will consist of 150 patients, male and female adults, who present with the
need for general surgery in which an ultrasonic dissection device and/or a vessel sealing
device will be utilized. Patients will be identified prospectively via consultation with the
general surgeon. Data will be collected addressing the following variables: versatility,
dissection time, vessel diameter, reliability, efficiency, tissue response, steam
production, blood loss, tissue response, thermal spread, desiccation and sealing time. A
tentative total of ten individual tissue specimens will be obtained by the surgeon during
surgery and after the utilization of the Sonicision Cordless Ultrasonic Dissection System.
The patient's histologic sample will be followed after surgery in order to determine
efficacy of the vessel seal. Subsequently, the patient's information will be deidentified
and the patient assigned a study number to which all further analysis will be tied. Patient
participation will include time of surgery through discharge from the hospital. Study data
will be collected and managed utilizing an electronic database.

Inclusion Criteria:

General surgery in which an ultrasonic dissection device will be utilized Adult male and
females age 18 and older

Exclusion Criteria:

Surgery involving bone Surgery involving contraceptive tubal occlusion Indication for
emergency surgery Suspected inability or the inability to comply with trial procedures
Employee at the investigational center, sponsor or sponsor's representative, relative or
spouse of the investigator Emergency Surgery