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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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The Efficacy of Clenpiq utilized per FDA labeling, with a low residue diet the day before colonoscopy.
This study proposes to assess the use of a low residue diet of a prescribed nature the day before colonoscopy for breakfast, lunch and early dinner. Clinical outcomes utilizing the low residue diet will be compared to the Food and Drug Administration (FDA) approved split dose labeling, including the traditional clear liquid diet the day before colonoscopy utilizing the Clenpiq (Ferring Pharmaceuticals) bowel preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Clear Liquid Arm | Active Comparator | Following instructions with FDA-labeled clear liquids |
|
| Low Residue Diet Arm | Experimental | Following instructions for a low residue diet along with FDA-labeled clear liquids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Residue Diet | Other | Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Statistical equivalence of the clear liquid and low residue cohorts | Using the Boston Bowel Preparation Score, the 3 sections of the colon will be graded on adequacy of preparation at the colonoscopy | During Colonoscopy Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection Rate | Number of polyps detected and removed per total number of patients in each arm | Post Procedure Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria would include;
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Bertiger, MD | Hillmont GI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillmont GI | Flourtown | Pennsylvania | 19031 | United States |
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single blind trial of FDA approved preparation with per labeling clear liquid diet versus a single day low residue diet
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Investigator will be ignorant of how preparation was taken