NCT01929928

Brief Summary

The purpose of this study is to test the efficacy of a new cordless ultrasonic dissection system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration 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

January 1, 2013

Completed
8 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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 27, 2022

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

August 23, 2013

Last Update Submit

April 20, 2022

Conditions

Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (2)

  • Placement of Sonicision Cordless Ultrasonic Dissection 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 seals to achieve hemostasis, number of activations, number of successful seals, number of failed seals, tissue sticking, tissue color, thermal spread and desiccation.

    1 year

  • Efficacy of Sonicision Cordless Ultrasonic Dissection 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

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

Patients from the division of Hepatobiliary Surgery at Carolinas Medical Center in Charlotte, NC.

You may qualify if:

  • General surgery in which an ultrasonic dissection device will be utilized Adult male and females age 18 and older

You may not qualify if:

  • Surgery involving bone Surgery involving contraceptive tubal occlusion Indication for emergency surgery Suspected inability or the inability to comply with trial procedures Employee at the investigational center, sponsor or sponsor's representative, relative or spouse of the investigator Emergency Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Study Officials

  • David A 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

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

April 27, 2022

Record last verified: 2016-02

Locations

US(1)