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| Name | Class |
|---|---|
| US Endoscopy | INDUSTRY |
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The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.
The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iSnare with Gonak solution | Experimental |
| |
| Snaremaster braided snare with Gonak solution | Experimental |
| |
| iSnare with saline solution | Experimental |
| |
| Snaremaster braided snare with saline solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Procedure as described in ARM | Procedure | Standard of Care Procedure as described in ARM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Two Devices used in EMR | To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" . | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Use of Two Injectates | To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy A Woodward, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |