PillCam® Platform With the PillCam Crohn's Disease Capsule
PillCam® Platform With the PillCam Crohn's Disease Capsule
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the
 effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by
 visualizing the small bowel and colon in patients with active symptoms associated with
 Crohn's disease (CD).
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the
 diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with
 symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have
 evidence of active symptoms associated with Crohn's disease. Each subject will be required to
 follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy
 procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy
 procedure may be done the following day per physician discretion. If the ileocolonoscopy
 procedure is done within 24 hours from the CE procedure, the subject will stay on clear
 liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections
 below:

 Visit 1; Screening visit

 -  Informed consent process

 -  screening for eligibility to participate in the study

 -  Inclusion/exclusion criteria

 -  Small bowel patency test

 -  Demographic data

 -  Pregnancy test

 -  General medical history

 Visit 2; PillCam® Crohn's capsule ingestion

 -  PillCam® CD bowel preparation

 -  Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)

 -  Ileocolonoscopy with intubation of terminal ileum

 Follow up period (5-9 days following visit 2)

 • CE Follow up telephone contac
Inclusion Criteria:

 1. Subject ages 18-75 years, inclusive

 2. Subject has known CD and signs and symptoms of active disease including one of the
 following:

 -  Chronic diarrhea

 -  Chronic abdominal pain

 -  Rectal bleeding

 3. Subject has at least one of the following within three months of enrollment:

 -  Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal
 lactoferrin, fecal alpha-1 antitrypsin)

 -  Anemia (hemoglobin level below normal reference range)

 -  Hypoalbuminemia (albumin below normal reference range)

 -  Weight loss

 4. Proven patency by the Agile capsule or another approach deemed clinically acceptable
 by the investigator, e.g. CT enterography, performed within the 90 days prior to
 enrollment.

 5. Subject agrees to sign consent form

 Exclusion Criteria:

 1. Indeterminate Colitis

 2. Ulcerative Colitis

 3. Antibiotic Associated Colitis

 4. Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months
 of enrollment

 5. Other known infectious cause of increased symptoms

 6. Known history of intestinal obstruction or current obstructive symptoms, such as
 severe abdominal pain with accompanying nausea or vomiting, based on investigator
 judgment.

 7. Definite long stricture seen on radiological exam.

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

 9. Suspected GI stricture, followed by Pillcam Patency study or other imaging study that
 could not prove patency of the GI tract.

 10. Subject 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.

 11. Subject is expected to undergo MRI examination within 7 days after ingestion of the
 capsule.

 12. Subjects with known or suspected delayed gastric emptying

 13. Subjects with known or suspected delayed Small bowel motility

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

 15. Subject has Type I or Type II Diabetes.

 16. Subject has any allergy or other known contraindication to the medications used in the
 study.

 17. Subject has any condition, which precludes compliance with study and/or device
 instructions.

 18. 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.

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

 20. Subject suffers from a life threatening condition.

 21. Subject with a history or clinical evidence of renal disease and/or previous
 clinically significant laboratory abnormalities of renal function parameters.