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CompletedNCT01929902Updated Apr 27, 2022

Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery

An observational study in Cancer, Hepatocellular and Pancreatectomy, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer, Hepatocellular
  • Pancreatectomy

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03

In context

Liver Neoplasms

1,390 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 20 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Surgical Patients
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. Device Complications

    Functional evaluation of device based on the variable: device malfunction.

    Time frame: 1 year

07

Study locations

1 site
  • Carolinas Healthcare System
    Charlotte, North Carolina 28204, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01929902
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Aug 28, 2013
Start date
Jul 2013
Primary completion
Jan 2014
Completion
Mar 2014
Last update
Apr 27, 2022

Study contacts

David Iannitti, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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