PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Purpose of study:

To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy

Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects

Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy

Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months

Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time

Inclusion Criteria:

• Subject is >/= 18 years
• Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
• Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum >45 min), adverse reaction to sedation requiring termination of colonoscopy

Exclusion Criteria:

• Subject has dysphagia or any swallowing disorder
• Subject has severe congestive heart failure or renal insufficiency
• Subject with high risk for capsule retention
• Subject has a cardiac pacemakers or other implanted electromedical devices
• Subject has any allergy or other contraindication to the medications used in the study
• Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study
• Colonoscopy had been performed by a physician who has experience of <1000 complete colonoscopies
• Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
• Time interval between incomplete colonoscopy and capsule endoscopy >30 days