Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Study Overview
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Brief Summary
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This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure

Detailed Description
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This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months . Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease

Official Title
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Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

Conditions
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Known Crohn Disease Subjects

Intervention / Treatment
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* Device: Capsule endoscopy and Ileocolonoscopy tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ages 2-75 years, inclusive Subjects with a diagnosis of known Crohn disease Referred to ileocolonoscopy (up to 4 weeks before the CE procedure) Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment. Subject or parent agrees to sign consent form Exclusion Criteria: The presence of any of the following will exclude a subject from study enrollment: Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy Stricture seen on radiological exam. Indeterminate Colitis Ulcerative Colitis Antibiotic Associated Colitis Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. Subjects with known or suspected delayed gastric emptying Subjects with known or suspected delayed Small bowel motility Subject has any allergy or other known contraindication to the medications used in the study. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception. Unwillingness to use a medically accepted method of contraception throughout duration of study Concurrent participation in another clinical trial using any investigational drug or device. Subject has cardiac pacemaker or other implanted electromedical devices Subject suffers from a life threatening condition. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capsule endoscopy<br> | Device: Capsule endoscopy and Ileocolonoscopy tests<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific cutoff | 6 months changefrom Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline. SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific | Baseline | 
| Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific cutoff | 6 months change from Baseline | 
| Evaluate the Entire SB CE Scores | Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS). Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific | 6 months change from Baseline | 
| Adverse Events (AE) | To assess safety related to capsule retention and other adverse events | 6 months |