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Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections

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ClinicalTrials.gov Identifier: NCT02519140
Recruitment Status : Unknown
Verified February 2016 by Danny A Sherwinter, Maimonides Medical Center.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center

Brief Summary:
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Condition or disease Intervention/treatment Phase
Gastric Cancer Colon Cancer Drug: Cook Medical EMR Gel Phase 3

Detailed Description:
This is a study to determine how the viscosity (thickness) of an FDA approved gel made by Cook medical affects the ease in which endoscopic mucosal resections (EMR) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. The lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent EMR dissection can be performed. These characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections
Study Start Date : August 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cook medical EMR Gel

Prospective study involving excised human stomachs and colon harvested from sleeve gastrectomies and colectomies performed for benign or malignant disease.

Different Cook submucosal injections of varying viscosities will be injected into different areas of the excised stomachs or colons.

Data collected will involve lifting characteristics and dissection adequacy of the varying viscosities of gel.

Drug: Cook Medical EMR Gel
Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
Other Name: Cook Medical EMR Gel will be injected submucosally



Primary Outcome Measures :
  1. Lift Efficacy [ Time Frame: 1 hour ]
    Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.


Secondary Outcome Measures :
  1. Dissection Adequacy [ Time Frame: 1 hour ]
    Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pts undergoing sleeve gastrectomy
  • Pts undergoing colectomy

Exclusion Criteria:

  • Unable to give or understand consent
  • All of the excised tissue will be needed for diagnostic purposes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519140


Contacts
Contact: Danny A Sherwinter, MD 7182837952 dsherwinter@maimonidesmed.org
Contact: Julya Fuzaylova 7182837952 jfuzaylova@maimonidesmed.org

Locations
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Danny A Sherwinter, MD    718-283-7952    dsherwinter@maimonidesmed.org   
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Danny Sherwinter, MD Maimonides Medical Center

Publications:
Responsible Party: Danny A Sherwinter, Chief Minimally Invasive Abdominal and Bariatric Surgery, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02519140     History of Changes
Other Study ID Numbers: 2014-05-06
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Danny A Sherwinter, Maimonides Medical Center:
Gastric cancer
colon cancer
EMR
biopsy
bariatric surgery

Additional relevant MeSH terms:
Stomach Neoplasms
Colonic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases