PillCam® Platform With the PillCam Crohn's Disease Capsule

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.