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The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCamĀ® procedure, colon cleanliness and capsule excretion time.
Interim analysis will be done after 20 subjects are enrolled in order to assess the 1st arm. Following the analysis of the first phase results, and per need, 30 more subjects may be enrolled under a different regimen (2nd arm). Second Interim analysis will be done in order to assess the 2nd phase results. Following the analysis of the 2nd phase results, and per need, up to 30 additional subjects may be enrolled under a third regimen (3rd arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MgC boosts | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered MgC boosts. |
|
| Suprep boosts | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered Suprep boosts |
|
| Suprep boosts - Reduced dose | Experimental | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects will be administered a reduced dose of Suprep boosts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCamĀ® COLON 2 procedure using MgC boosts | Other | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts. |
| Measure | Description | Time Frame |
|---|---|---|
| Capsule excretion rate | 10 hours post capsule ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of PillCamĀ® COLON 2 excretion times | Up to 12 hours and at least 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Rex, Prof. | Division of Gastroenterology Indiana University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Digestive Disorders Center | Huntsville | Alabama | 35802 | United States | ||
| Division of Gastroenterology Indiana University Medical Center |
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| PillCamĀ® COLON 2 procedure using Suprep boosts | Other | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts |
|
| PillCamĀ® COLON 2 procedure using reduced dose of Suprep boosts | Other | Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts |
|
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Research Associates of New York | New York | New York | 10075 | United States |
| University of North Carolina Division of Digestive Disease | Chapel Hill | North Carolina | 27599 | United States |
| Digestive Care, Inc. | Beavercreek | Ohio | 45440 | United States |
| Franklin Gastroenterology | Franklin | Tennessee | 37067 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |