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The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients.
Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bowel prep regimen first boost 6 oz. and second boost 3 oz. | Experimental | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI |
|
| bowel prep regimen first boost 3 oz. and second boost 6 oz. | Experimental | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bowel prep regimen first boost 6 oz. and second boost 3 oz. | Other | Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost) |
| Measure | Description | Time Frame |
|---|---|---|
| • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients | effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted. | The end points and outcomes measures will be evaluated within 4 months from end of enrollment |
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Inclusion Criteria:
Subject is 18 years of age and above
Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :
Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
Subject is able and agrees to sign the Informed Consent Form
Exclusion Criteria:
• Subject has dysphagia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States | ||
| Dayton Gastroenterology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost) |
| FG001 | Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients | effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted. | Posted | Number | 95% Confidence Interval | percentage of participants | The end points and outcomes measures will be evaluated within 4 months from end of enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse event related to the preparation | Gastrointestinal disorders | adverse events were reported as related to the the preparation such as vomiting and nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ravit Peled | Clinical Trials Manager | Given Imaging | +972 (4) 909-7894 | 7894 | Ravit.peled@covidien.com |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| bowel prep regimen first boost 3 oz. and second boost 6 oz. | Other | Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) |
|
| Beavercreek |
| Ohio |
| 45440 |
| United States |
| BG001 | Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) |
|
|
| 0 |
| 21 |
| 9 |
| 21 |
| EG001 | Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz. | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) | 0 | 19 | 4 | 19 |
|
| Adverse event not related to study procedure | Gastrointestinal disorders | adverse events were reported as not related to the study procedure such as fever and headache |
|
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| D007410 | Intestinal Diseases |