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Withdrawn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.
|
|
|
Active Comparator: Standard Dissection Method
For patients in the control group, blunt dissection will be performed by standard 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.
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.