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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01929902

Enrollment

Registered

2013-08-28

Start date

2013-07-31

Completion date

2014-03-31

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Hepatocellular, Pancreatectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

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

Countries

United States

Outcome results