This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
74
Mayo Clinic
Scottsdale, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Borland-Groover Clinic
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
Time frame: 6 months changefrom Baseline
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
Time frame: 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
Time frame: 6 months change from Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jacksonville, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Indiana Unveresity Hospital
Indianapolis, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
...and 5 more locations
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
Time frame: 6 months change from Baseline
Adverse Events (AE)
To assess safety related to capsule retention and other adverse events
Time frame: 6 months