Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.

This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE
for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known
CD and mucosal disease.

A screening visit will be performed within 30 days prior to baseline procedures to assess
pre-procedure eligibility. At this visit the following assessments will be performed:
Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification,
Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy
tests.

At baseline, subjects with known CD on routine evaluation (e.g. history, physical exams,
labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on
radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease
based on clinical judgment based on symptoms, laboratory data or other clinical information
will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and
Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel.
Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy
test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events.

Subjects will be exited from the study once all Baseline Procedures have been completed and
AEs resolved.

All CE videos, IC videos and MRE images will be evaluated by central readers.

The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the
United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5
years. The expected duration of each subject's participation is approximately 1 month.

Inclusion Criteria:

- Subject has provided informed consent.

- Subject is ≥ 18 years of age

- Subject is willing and able to comply with all aspects of treatment and evaluation
schedule.

- Subject has known CD and a recent history (within last 2 years) of mucosal disease
(based on radiologic, endoscopic, or histologic evidence) OR known CD and active
disease, based on clinical judgment based on symptoms, laboratory data or other
clinical information.

Exclusion Criteria:

- Subject has indeterminate, ulcerative, antibiotic-associated colitis.

- Subject has stool positive for ova and parasite and for Clostridium difficule toxins
within 3 months prior to enrollment.

- Subject with other known infectious cause of abdominal symptoms.

- Subject with clinical evidence of renal disease with the past 6 months, defined as
estimated glomerular filtration rate (GFR) outside the normal reference range.

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

- Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.

- Subject with suspected or known bowel obstruction, stricture (defined as unequivocal
proximal upstream dilation equal ≥ 2.5 cm), or fistula.

- Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times
per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (≤ 100 mg
daily) are acceptable and not exclusionary.

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

- Subject with cardiac pacemaker or other implanted electromedical device.

- Subject has an allergy or other known contraindication to the medications used in the
study.

- Subject is pregnant (documented by a positive pregnancy test) or is actively
breast-feeding.

- Subject is considered to be a part of a vulnerable population (eg. prisoners or those
without sufficient mental capacity).

- Subject has a known contraindication to MRE or IC.

- Subject has participated in a drug or device research study within 30 days of
enrollment that may interfere with the subject's safety or ability to participate in
the study.

- Subject has any medical condition that would make it unsafe for them to participate,
per Investigator's discretion

- Subject with ileostomy or colostomy, history of total or subtotal colectomy (including
those with ileosigmoidostomy, and ileorectostomy)