NCT01929902

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

August 23, 2013

Last Update Submit

April 20, 2022

Conditions

Cancer, HepatocellularPancreatectomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Device Complications

    1 year

Study Arms (1)

Surgical Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • David Iannitti, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 28, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

April 27, 2022

Record last verified: 2014-04

Locations

US(1)