Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative of Ulcerative Colitis Disease
Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative of Ulcerative Colitis Disease
Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of
 the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and
 clinical impact of IBD capsule in detecting lesions associated with UC Disease and to
 determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy
 in the evaluation of UC disease extent.

 Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical
 colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided
 colitis, Pancolitis)

 Proposed Design Established UC disease patients whose clinical condition suggests ongoing
 disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or
 other obstruction that would prevent capsule passage will be enrolled in this study.

 Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and
 colonoscopy examination.

 The Rapid videos will be evaluated by two readers, each from a different site, the
 colonoscopy videos will be evaluated by two other physicians, at the sites

 INCLUSION CRITERIA

 All subjects must fulfill all of the following inclusion criteria:

 -  Patients ages 18 years and up

 -  Patient has known UC according to physician discretion

 -  Patient has at least one positive inflammatory marker from the following:

 -  ESR

 -  CRP

 -  CBC

 -  Patient is indicated and eligible for a standard of care colonoscopy examination

 -  Patient agrees to sign consent form

 EXCLUSION CRITERIA

 The presence of any of the following will exclude a patient from study enrollment:

 -  Crohn's Disease

 -  Antibiotic Associated Colitis

 -  Stool positive for O&P (C&S within 3 months of enrollment)

 -  Other known infectious cause of increased symptoms

 -  Known intestinal obstruction or current obstructive symptoms, such as severe abdominal
 pain with accompanying nausea or vomiting.

 -  Definite long stricture seen on radiological exam.

 -  Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during
 the 4 weeks preceding enrollment

 -  Suspected GI stricture, followed by patency capsule study or other imaging study that
 could not prove patency of the GI tract.

 -  Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6
 months, other than uncomplicated procedures that would be unlikely to lead to bowel
 obstruction based on the clinical judgment of the investigator.

 -  Patient is expected to undergo MRI examination within 7 days after ingestion of the
 capsule.

 -  Patient with known gastrointestinal motility disorders.

 -  Subjects with known or suspected delayed gastric emptying

 -  Patient suffers from any condition, such as swallowing problems, which precludes
 compliance with study and/or device instructions.

 -  Patient has Type 1 or Type II Diabetes.

 -  Patient has any allergy or other known contraindication to the medications used in the
 study.

 -  Patient has any condition, which precludes compliance with study and/or device
 instructions.

 -  Women who are either pregnant or nursing at the time of screening, or are of
 child-bearing potential and do not practice medically acceptable methods of
 contraception.

 -  Concurrent participation in another clinical trial using any investigational drug or
 device.

 -  Patient suffers from a life threatening condition

 -  Patients with history or clinical evidence of renal disease and/or previous clinically
 significant laboratory abnormalities of renal function parameters.
Inclusion Criteria:

 -  Patients ages 18 years and up

 -  Patient has known UC according to physician discretion

 -  Patient has symptoms of fresh bleeding and/or bloody diarrhea and/or at least one
 positive inflammatory marker within the past three months from the following:

 -  ESR

 -  CRP

 -  CBC

 -  Patient is indicated and eligible for a standard of care colonoscopy examination for
 evaluation of disease activity and not for routine screening for dysplasia or
 colorectal cancer

 -  Patient agrees to sign consent form

 Exclusion Criteria:

 -  Crohn's Disease

 -  Antibiotic Associated Colitis

 -  Stool positive for O&P and for C. difficile toxin within 3 months of enrollment

 -  Other known infectious cause of increased symptoms

 -  Known intestinal obstruction or current obstructive symptoms, such as severe abdominal
 pain with accompanying nausea or vomiting.

 -  Definite tight or long stricture seen on radiological exam.

 -  Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during
 the 4 weeks preceding enrollment

 -  Suspected GI stricture, followed by patency capsule study or other imaging study that
 could not prove patency of the GI tract.

 -  Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6
 months, other than uncomplicated procedures that would be unlikely to lead to bowel
 obstruction based on the clinical judgment of the investigator.

 -  Patient is expected to undergo MRI examination within 7 days after ingestion of the
 capsule.

 -  Patient with a known gastrointestinal motility disorder.

 -  Subjects with known or suspected delayed gastric emptying

 -  Patient suffers from any condition, such as swallowing problems, which precludes
 compliance with study and/or device instructions.

 -  Patient has Type 1 or Type II Diabetes.

 -  Patient 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 practice medically acceptable methods of
 contraception.

 -  Concurrent participation in another clinical trial using any investigational drug or
 device.

 -  Patient suffers from a life threatening condition

 -  Patients with history or clinical evidence of renal disease and/or previous clinically
 significant laboratory abnormalities of renal function parameters.