Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon
for performance of colonoscopy.

Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention,
patient's discomfort, use of sedatives and analgetics during procedure and will simplify the
performance of colonoscopy resulting in shortening of procedure time and increasing the rate
of cecal intubation.

Specific aims of the study:

1. To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy
with traditional CO2-insufflation colonoscopy.

2. To compare safety profiles between traditional CO2-insufflation colonoscopy and
colonoscopy using the "Visualization" Balloon.

4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with
"Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with
standard colonoscopy using CO2 insufflation.

4.2 Secondary Outcomes

To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in
regards of:

1. Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the
procedure.

2. Ease of colonoscope insertion.

3. The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time
and total procedure time.

5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7.
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24
hours post procedure.

8. Complications during and after colonoscopy. 9. Polyp detection rate.

Inclusion Criteria:

1. The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or
for diagnostic workup.

2. Subject is able to understand the risks and benefits of participating in the study and
must be willing to sign and date the Informed Consent Form for this study approved by
the Institutional Review Board (IRB.)

3. Age from 17 to 90 years.

4. Be willing and able to comply with the requirements of the protocol.

5. Be willing to refrain from participating in any other investigational interventional
study while enrolled in this study.

6. Female subjects must have a negative pregnancy test within the last 24 hours timeline
and have no intentions of becoming pregnant during participation in the study, or be
sterilized.

Exclusion Criteria:

1. Subjects with a history of previous colonic resection.

2. Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less
than 50,000).

3. Subjects unwilling or unable to give written consent to participate in the
investigation or unable to comply with the requirements of the protocol.

4. Subjects with suspected colonic strictures potentially precluding complete
colonoscopy.

5. Subjects who received any experimental drug or device within the previous three
months.

6. Female subjects who were pregnant or lactating or were intending to become pregnant
during the period of the study, or who would not use an adequate method of
contraception (contraceptive pill, intra-uterine device) for the duration of the
study.

7. Subjects who possessed any psychological condition, or were under treatment for any
condition which, in the opinion of the Investigator and/or consulting physicians(s),
would constitute an unwarranted risk.