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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Maimonides Medical Center
Sponsor:
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT02519140
First received: August 17, 2014
Last updated: February 21, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Gastric Cancer
Colon Cancer
Drug: Cook Medical EMR Gel
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing How the Viscosity of Submucosal Gel Injections Helps With Endoscopic Mucosal Resections

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Lift Efficacy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.


Secondary Outcome Measures:
  • Dissection Adequacy [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure.


Estimated Enrollment: 32
Study Start Date: August 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: August 17, 2014
Last Updated: February 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on July 21, 2016