Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Pancreatectomy; Cancer, Hepatocellular

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients age 18 years or older and in need of general surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgical Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Complications	Functional evaluation of device based on the variable: device malfunction.	1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (ESTIMATE): August 28, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 07-13-04E