Clinical trial NCT01929902: Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery
Official title: Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer, Hepatocellular
Pancreatectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients age 18 years or older and in need of general surgery.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the Aquamantys Device
timeFrame: 1 year
measure: Placement of Aquamantys Device
timeFrame: 1 year
Secondary outcomes:
measure: Device Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Iannitti, MD
role: PRINCIPAL_INVESTIGATOR
References: