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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Device Complications | Functional evaluation of device based on the variable: device malfunction. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients age 18 years or older and in need of general surgery.
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| Name | Affiliation | Role |
|---|---|---|
| David Iannitti, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Healthcare System | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| D008107 |
| Liver Diseases |