Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

Wake Forest University (WFU)

Status: Completed

Conditions: Cancer, Hepatocellular; Pancreatectomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01929902

07-13-04E

Details and patient eligibility

About

The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for general surgery to include: liver resection and pancreatectomy
• Male or females age 18 years of age or older

Exclusion criteria

• Indication for emergency surgery
• Suspected inability, e.g. language problems or the inability to comply with trial procedures
• Employee at the investigational center, Sponsor or Sponsor's representative, relative or spouse of the investigator
• Females who are pregnant or breastfeeding

Trial design

20 participants in 1 patient group

Surgical Patients