Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability
of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal
disease activity in CD subjects after 6 months .

Up to 75 subjects will participate in this study. An interim analysis will be done after
study completion with 20 subjects. All subjects to be enrolled in this study will be
pediatric and\or adult subjects with known Crohn's disease

Inclusion Criteria:

1. Subject ages 2-75 years, inclusive

2. Subjects with a diagnosis of known Crohn disease

3. Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)

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

5. Subject or parent agrees to sign consent form

Exclusion Criteria:

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

1. Subjects with change in IBD drug therapy between the baseline ileocolonoscopy and VCE

2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA)
and J pouch or an ostomy

3. Stricture seen on radiological exam.

4. Indeterminate Colitis

5. Ulcerative Colitis

6. Antibiotic Associated Colitis

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

8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not
including aspirin up to 81mg daily, 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 is expected to undergo MRI examination within 7 days after ingestion of the
capsule.

11. Subjects with known or suspected delayed gastric emptying

12. Subjects with known or suspected delayed Small bowel motility

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

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

15. Unwillingness to use a medically accepted method of contraception throughout duration
of study

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

17. Subject has cardiac pacemaker or other implanted electromedical devices

18. Subject suffers from a life threatening condition.

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

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