Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

Completed

• Conditions: Pancreatectomy; Cancer, Hepatocellular

• Registration Number: NCT01929902
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-28
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Placement of Aquamantys Device	1 year	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.
Efficacy of the Aquamantys Device	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Device Complications	1 year	Functional evaluation of device based on the variable: device malfunction.

Trial Locations

Locations (1)

Carolinas Healthcare System; 🇺🇸 Charlotte, North Carolina, United States