Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery
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|ClinicalTrials.gov Identifier: NCT01929902|
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : May 2, 2014
|Condition or disease|
|Cancer, Hepatocellular Pancreatectomy|
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:
- Cone-shaped electrodes designed to aid blunt dissection;
- Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue;
- Bipolar electrodes alleviate the need for grounding pad;
- 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|
|Actual Enrollment :||20 participants|
|Official Title:||Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||March 2014|
- Efficacy of the Aquamantys Device [ Time Frame: 1 year ]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.
- Placement of Aquamantys Device [ Time Frame: 1 year ]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.
- Device Complications [ Time Frame: 1 year ]Functional evaluation of device based on the variable: device malfunction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929902
|United States, North Carolina|
|Carolinas Healthcare System|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||David Iannitti, MD||Atrium Health|