Trial Information

Feasibility, Multi-center Prospective Study of Check-Cap's P1 Capsule System in Patients Eligible for ColoRectal Cancer [CRC] Screening

Study Title:

Outside USA [OUS] Pilot Multi-center prospective feasibility study

Objectives:

Primary:

To establish the safety and preliminary efficacy of the Check-Cap System in patients with
negative FOBT (Fecal Occult Blood Test)

Secondary:

- To evaluate the safety of the device in terms of total and segmental transit time and
to study the effect of the presence of polyps and variable colon dimensions on these
parameters.

- To monitor the functionality of the activation mechanism and of the scanning circuitry
(transmitter detectors).

- To collect data about the overall imaging of the colon internal surface during the
passage of the capsule

- To develop a correlation map between the imaging of the polyps by optical colonoscopy
vs. the images of same polyps by the Check-Cap capsule vs. the imaging of same polyps
by CT Colonography (in patients which were referred after positive CTC examination)

- To estimate the total radiation exposure to each patient.

- To measure the distribution of the contrast material within the colon.

Design:

Prospective, Single arm, Multi-Center

Patient population:

Group A - First in Man:

Male and female subjects older than 50 and younger than 75 years old that are eligible for
CRC screening and meet the eligibility criteria for study enrollment.

The study population will be enriched with up to 45 patients with known polyps detected by
CTC or colonoscopy, in addition to 15 patient of the device's normal cohort.

All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal
Occult Blood Test) After the Capsule test, they will be referred for optical colonoscopy as
part of the study

Group B - CE Pilot:

Male and female subjects older than 50 and younger than 75 years old that are eligible for
CRC screening and meet the eligibility criteria for study enrollment.

All patients that are eligible for enrollment in the study will be tested by FOBT (Fecal
Occult Blood Test) Those tested NEGATIVE will be offered to ingest the capsule. After the
Capsule test they will be referred for optical colonoscopy Consenting patients with negative
FOBT testing scheduled for clinically-indicated optical colonoscopy without contraindication
to either Check-Cap System imaging or optical colonoscopy, and able to undergo the bowel
preparation necessary for optical colonoscopy.

Sample Size:

Total of 60 patients in both groups: A:3-5 + B: 55-57 subjects.

Study Procedure:

1. st visit - recruitment and screening meeting with the Principal Investigator [PI].
Subject will receive the FOBT test kit with detailed instructions for executing the
test.

2. nd visit - The FOBT kits will be analyzed in order to diagnose the presence of blood in
the stool.

In patients with NEGATIVE result the PI will examine the bowel log form. If it is
complete and the bowel frequency is not less than once per 2 days the subject will be
asked to sign the Informed Consent Form [ICF] for ingesting the capsule.

3. rd visit - Subject will ingest the capsule and continue ingestion of contrast material.

4. th visit - Subjects will return to the PI with the excreted capsule which is expected
within 24-100 hours after ingestion.

5. th visit - All patients will undergo standard bowel preparation and optical colonoscopy
between 10 and 30 days following imaging with the Check-Cap System.