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

Study Overview
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Brief Summary
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This is a study to determine how the viscosity (thickness) of an FDA approved gel affects the ease in which endoscopic mucosal resections (EMR) can be performed.

Detailed Description
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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.

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

Conditions
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Gastric Cancer, Colon Cancer

Intervention / Treatment
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* Drug: Cook Medical EMR Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cook medical EMR Gel<br>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<br>* Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens<br>* Other names: Cook Medical EMR Gel will be injected submucosally;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lift Efficacy | Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dissection Adequacy | Dissection adequacy which would be measured by time which the gel stays within the tissues. Anything less than one hour will be considered failure. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, Gastric cancer, colon cancer, EMR, bariatric surgery