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
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Colon Cancer||Drug: Cook Medical EMR Gel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Lift Efficacy [ Time Frame: 1 hour ]Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection.
- 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.
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
|Contact: Danny A Sherwinter, MDemail@example.com|
|Contact: Julya Fuzaylovafirstname.lastname@example.org|
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Danny A Sherwinter, MD 718-283-7952 email@example.com|
|Principal Investigator:||Danny Sherwinter, MD||Maimonides Medical Center|