EnSeal Efficacy and Bursting Pressure in Human Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Illinois at Chicago.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01312246
First received: March 9, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

In this study the investigators will include adult patients who are not part of a vulnerable patient population. Inclusion criteria include patients who will be undergoing resection of part of their colon that will require dividing the IMA. The investigators will use the resected surgical specimens for our project. The investigators will use the EnSeal on all major vessels in our procedure. The investigators will use the EnSeal 5 mm round head model. Due to the nature of the project, we will apply for IRB approval prior to beginning our research. The investigators plan to include 60 total patients in the study, 30 at the University of Illinois and 30 at Lutheran General Hospital.

Prior to resection, the investigators will use a sterile caliper to take an in-vivo measurement of the IMA and IMV. Immediately after resection, the investigators will remove the sealed proximal end of the IMA and the 3 cm distal to it from the surgical specimen. The investigators will similarly prepare the IMV. The investigators will inspect our vessels for any iatrogenic traumatic tears. If the vessels are suitable, the investigators will then gentle apply manual traction to remove any blood or clots within the lumen. The investigators will measure the outer diameter of the vessels using a digital caliper. If there are small branches, the investigators will tie them off with suture. The unsealed end will then be attached to the burst pressure tester with suture and it will be tested for the bursting pressure. The device measures pressure continuously as it infuses the segment with normal saline at a steady rate (50 ml/hr). A leak will be determined by a decrease in intra-luminal pressure of 100 mm Hg or a visible leak. A failure to seal the vessels will be determined by a bursting pressure of less than 100 mm Hg. It should be noted that each section would only be pressure-tested once. All of our data will be collected on the enclosed data sheet we have created for use in this protocol. The investigators will then place the vessels with the original surgical specimen where it will be submitted for routine pathological examination of surgical specimens. Twenty five specimens at each site will undergo the testing, whereas 5 specimens will be sent to pathology without testing.

Our pathologist will analyze the submitted specimen for extent of seal, disruption of vessel smooth muscle, gas bubbles, and will stain for elastin to analyze the disruption in the vessel wall. In addition, the seal will be measured and we will obtain digital images. The specimens submitted for pathology will be 5 burst specimens as well as 5 un-burst specimens taken from the pool of 25 patients at UIC.

For our human component, the investigators have estimated the standard deviation and width of the confidence interval to be 100 mm Hg each. With a 95% confidence level, the investigators expect to require 16 measurements for human specimens from 16 patients although the investigators will use 50 patients to allow for errors in obtaining pressures.

Our timeline for the completion of the projects is 6 months. The investigators plan on being able to complete the human burst pressure testing within 6 months.


Condition Intervention
Colon and Rectal Diseases
Device: EnSeal Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: EnSeal Efficacy and Bursting Pressure in Human Vessels

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • EnSeal Efficacy and Bursting Pressures in Human Vessels [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
    Demonstrate that the bursting pressures in large vessels (IMA, IMV) sealed in colectomy of human patients are sufficiently high. Using the EnSeal device on larger vessels, the investigators believe, would further reduce operating time, blood loss, and hasten post-operative recovery from less tissue manipulation.


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: EnSeal Device
    measurement of bursting pressure of colonic vessels after using the EnSeal Device
    Other Name: EnSeal Device- Ethicon Endo Surgery
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Include patients who will be undergoing resection of part of their colon that will require dividing the colonic vessels. The use of the resected surgical specimens is included our project.

Exclusion Criteria:

  • Patients who do not meet the the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312246

Contacts
Contact: Saeed s Albalawi, MD 3129619364 saeed_aradi@hotmail.com
Contact: Nathalie Mantilla, MD 312-996-5162 farfanmn@uic.edu

Locations
United States, Illinois
University Of Illinois Medical Center at Chicago Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Saeed S Abalawi, MD    312-961-9364    saeed_aradi@hotmail.com   
Contact: Nathalie Mantilla, MD    312-996-5162    farfanmn@uic.edu   
Sub-Investigator: SAEED S ALBALAWI, MD         
Principal Investigator: Leela M Prasad, MD         
Sub-Investigator: Marek Zawadzki, MD         
Sub-Investigator: VAMSI R VELCHURU, MD,FRCS         
Sub-Investigator: NATHALIE MANTILLA, MD         
Sub-Investigator: ARIANE ABCARIAN, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Ethicon Endo-Surgery
Investigators
Principal Investigator: Leela M Prasad, MD University of Illinois at Chicago
  More Information

Publications:

Responsible Party: Prasad Leela, university of Illinois
ClinicalTrials.gov Identifier: NCT01312246     History of Changes
Other Study ID Numbers: 2010-0878
Study First Received: March 9, 2011
Last Updated: March 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
vessel ligation
colon resection

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014