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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook medical EMR Gel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Medical EMR Gel | Drug | Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lift Efficacy | Lifting characteristics which would be measured by height of the mucosa after submucosal gel injection. | 1 hour |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danny Sherwinter, MD | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23392984 | Background | Chandrasekhara V, Sigmon JC Jr, Surti VC, Kochman ML. A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Surg Endosc. 2013 Aug;27(8):3039-42. doi: 10.1007/s00464-013-2813-y. Epub 2013 Feb 8. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |