Clinical Trial: Evaluation of Small Bowel Colon Capsule for Bowel Visualization in Crohn's Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Evaluation of Small Bowel Colon Capsule for Bowel Visualization in Crohn's Disease Patients

Brief Summary:

Study Hypothesis:

It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon. As such, the system may be utilized in CD patients for monitoring mucosal healing.

Primary objectives:

To evaluate two different video output methods in the visualization of the SB and colon in CD patients

Secondary objectives:

• Evaluate the level of agreement between PillCam system and ileocolonoscopy on the assessment of CD findings.
• Evaluate the effectiveness of PillCam regimen in CD patients

Inclusion criteria

• Patient is 18 years of age and above
• Patient with a diagnosis of ileocolonic or colonic Crohn's Disease documented by endoscopical, histopathological and/or radiological parameters
• Patients' CDAI >150.
• Patient is clinically indicated to undergo ileocolonoscopy for assessment of Crohn's disease
• Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
• Patient is able and agrees to sign the Informed Consent Form

Exclusion criteria

• Patient has dysphagia
• Study design: Multi-center, prospective study Number of subjects: Up to 30 study duration: up to 18 months Subject population: Subjects with moderate to severe Crohn's disease demonstrating colon involvement who are indicated to undergo standard ileocolonoscopy as part of their disease management

  Study Design:

  1. Each patient will undergo PillCam, procedure followed by conventional ileocolonoscopy procedure with intubation of the terminal ileum

  2. During the ileocolonoscopy procedure, the colonoscopist will document his findings according to the parameters defined in the SES-CD score and the overall assessment in the following segments:

     1. Rectum
     2. Left colon (including sigmoid)
     3. Transverse colon
     4. Right colon
     5. Terminal ileum
  3. Cleansing level for the ileocolonoscopy procedure will be assessed at each site
  4. From each capsule endoscopy procedure two RAPID video versions will be generated and segmented into segments
  5. A committee composed of the study investigators will review all the RAPID video segments and document their findings according to the parameters defined in the SES-CD, Lewis and CECDAI scoring systems and an overall assessment
  6. The parameters for each segment per each of the two RAPID movies will be compared and the preferable video setup will be chosen
  7. Final RAPID and colonoscopy movies will be de-identified in regard
     Sponsor: Given Imaging Ltd.
     

     Current Primary Outcome: Agreement level between two PillCam videos, simulating different proposed system setups, on the severity and extent of CD lesions,up to 24 months [ Time Frame: up to 24 months ]
     
     

     Original Primary Outcome: Agreement level between two PillCam videos, simulating different proposed system setups, on the severity and extent of CD lesions, [ Time Frame: within five months ]
     
     

     Current Secondary Outcome:

     • Agreement level between PillCam and conventional ileocolonoscopy on the severity and extent of CD lesions, at colon and terminal ileum, based on the SES-CD score parameters and an overall assessment per each segment, up to 24 months [ Time Frame: up to 24 months ]
     • Capsule transit time statistics within stomach, small bowel and colon segments,up to 24 months [ Time Frame: up to 24 months ]
     • Capsule excretion time statistics, up to 24 months [ Time Frame: up to 24 months ]
     • Assessment of colon and SB cleansing level at different colon and SB,up to 24 months [ Time Frame: up to 24 months ]
     • Number, type and severity of adverse events, up to 24 months [ Time Frame: up to 24 months ]
     
     
     

     Original Secondary Outcome:

     • Agreement level between PillCam and conventional ileocolonoscopy on the severity and extent of CD lesions, at colon and terminal ileum, based on the SES-CD score parameters and an overall assessment per each segment [ Time Frame: within 7 months ]
     • Capsule transit time statistics within stomach, small bowel and colon segments [ Time Frame: within seven months ]
     • Capsule excretion time statistics [ Time Frame: within 7 months ]
     • Assessment of colon and SB cleansing level at different colon and SB [ Time Frame: within seven months ]
     • Number, type and severity of adverse events [ Time Frame: within seven months ]
     
     
     Information By: Given Imaging Ltd.
     

     Dates:
     Date Received: November 1, 2010
     Date Started: October 2010
     Date Completion:
     Last Updated: August 22, 2012
     Last Verified: August 2012