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Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

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ClinicalTrials.gov Identifier: NCT01929902
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
David Iannitti, Atrium Health

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

Condition or disease
Cancer, Hepatocellular Pancreatectomy

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy
Study Start Date : July 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2014

Group/Cohort
Surgical Patients



Primary Outcome Measures :
  1. Efficacy of the Aquamantys Device [ Time Frame: 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.

  2. Placement of Aquamantys Device [ Time Frame: 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 Outcome Measures :
  1. Device Complications [ Time Frame: 1 year ]
    Functional evaluation of device based on the variable: device malfunction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients age 18 years or older and in need of general surgery.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929902


Locations
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United States, North Carolina
Carolinas Healthcare System
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Atrium Health
Medtronic
Investigators
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Principal Investigator: David Iannitti, MD Atrium Health
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Responsible Party: David Iannitti, PI, Atrium Health
ClinicalTrials.gov Identifier: NCT01929902    
Other Study ID Numbers: 07-13-04E
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases