The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.
The primary objective of this study is to assess the efficacy of placement and accuracy of the Aquamantys device in 20 patients that require general surgery. High frequency electrosurgery is the application of frequency in the range of 300 kHz up to several MHz in order to coagulate or destroy tissue. Due to technological advancements, knowledge of how frequency and other physical modes interact with biological materials has become increasingly important in order for the surgeon to provide a safe and consistent surgery. The Aquamantys system utilizes radiofrequency energy and saline irrigation for cutting tissue and stopping excessive bleeding. The Aquamantys system features the following: 1. Cone-shaped electrodes designed to aid blunt dissection; 2. Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue; 3. Bipolar electrodes alleviate the need for grounding pad; 4. Transcollation technology allows for controlled depth of energy penetration. During surgery, the Aquamantys device will be utilized in order to stop excessive bleeding and to cut vessels. The patient will be monitored by the surgeon and research nurse coordinator before surgery, intra-operatively and post-operatively until discharge from the hospital. The study participant will follow-up post-operatively with the surgeon per standard of care.
Study Type
OBSERVATIONAL
Enrollment
20
Carolinas Healthcare System
Charlotte, North Carolina, United States
Efficacy of the Aquamantys Device
Efficacy of device will be measured based on intra-operative and post-operative complication variables: estimated blood loss, blood transfusion, complications intra-operative and post-operative.
Time frame: 1 year
Placement of Aquamantys Device
Evaluation of device placement will be measured based on vessel sealing variables: number of applications, vessel site, type of tissue to be sealed, number of failed and successful seals, tissue sticking, tissue color, thermal spread and desiccation.
Time frame: 1 year
Device Complications
Functional evaluation of device based on the variable: device malfunction.
Time frame: 1 year
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