An observational study in Cancer, Hepatocellular and Pancreatectomy, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Wake Forest University Health Sciences · Observational
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:
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.
1,390 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 20 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male and female patients age 18 years or older and in need of general surgery.
Exclusion Criteria:
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
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences