Pilot Study Differential Dissector™ for Blunt Dissection

August 3, 2016 updated by: University of North Carolina, Chapel Hill
The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than 18
  • Patient will be undergoing open abdominal surgery
  • Patient willing and able to provide his/her own consent

Exclusion Criteria:

  • Current alcohol or other substance abuse
  • Current incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Differential Dissector
For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate.
Device: Differential Dissector
Active Comparator: Standard Dissection Method
For patients in the control group, blunt dissection will be performed by standard method.
Other: Standard Dissection Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative Blood Loss
Time Frame: From start of surgery to wound closure
From start of surgery to wound closure
Post-operative Blood Loss
Time Frame: After surgical closure and drain insertion through drain removal
After surgical closure and drain insertion through drain removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Mark Koruda, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-2888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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