Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

Pancreatectomy Clinical Trial

Official title:

Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929902
• Other study ID #: 07-13-04E
• Status: Completed
• Start date: July 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Hepatocellular
• Liver Neoplasms
• Pancreatectomy

Locations

Country	Name	City	State
United States	Carolinas Healthcare System	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Device Complications	Functional evaluation of device based on the variable: device malfunction.	1 year