Post Market Evaluation of Aer-O-Scope Visualization

Subjects will be randomized in blocks of twenty (20) for either Aer-O-Scope or conventional
colonoscopy as the first procedure. Physicians will be notified of the procedural order
immediately prior to first colonoscopy. Up to the first ten (10) cases for each physician
(system operation training cases) will all begin with the Aer-O-Scope colonoscopy as the
first procedure.

The primary endpoint of AMR was chosen as this measure appears to be related to the
performance of colonoscopy and reduction in colorectal cancer incidence. During the course of
the last decade, several major visualizations studies have been performed and it has become
common practice to use the "second-pass" method for measuring colonoscopy visualization
methods, iii, iv. In the "second-pass" method, during the course of the first colonoscopy,
all visualized lesions are removed (or tattooed in the event that they cannot be removed for
any reason.). Any unmarked abnormalities discovered during the second pass colonoscopy are
considered to be missed pathologies for the first pass colonoscopy.

All endpoints related to timing will be measured using a stopwatch and overall time stamp
from the Aer-O-Scope or conventional colonoscope. Time to perform therapeutic interventions
with Aer-O-Scope as well as a description of said interventions will also be recorded. The
same instruments will be used to measure all procedures and will be calibrated as dictated by
the manufacturer.

All equipment used during the course of this clinical investigation will undergo calibration
and testing as per the manufacturing instructions. The Aer-O-Scope Colonoscope System has an
automated calibration system and diagnostic test that run daily. Conventional colonoscopes
will be maintained as per hospital/manufacturer protocol.

Recruited subjects who are withdrawn as a result of poor bowel prep or any other medical
determination leading to the inability to undergo colonoscopy and/or tandem colonoscopy will
be replaced. A poor prep is defined as having a score of score of 0 or 1 in the Boston Bowel
Preparation Scale (BBPS). The BBPS scores are as follows:

0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.

1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not
well seen due to staining, residual stool and/or opaque liquid.

2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but
mucosa of colon segment seen well.

3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of
stool or opaque liquid.

Any subject withdrawn as a result of physician discretion due to concomitant medical issues
will be withdrawn prior to the actual colonoscopic procedures. Patients with a large polyp
(>20mm) removed during the first pass with a conventional colonoscope will be withdrawn.
Patients who receive treatment during the first pass with clips (no other option available)
will be withdrawn.

Coagulation therapy should be performed either with Argon Plasma Coagulation (APC) or another
cautery tool or contact thermal device as per clinical protocol. For the purpose of this
clinical investigation, clips should not be used unless there is no alternative. Patients
treated with clips prior to their final pass colonoscopy, will be withdrawn from the
investigation.

Physicians may also withdraw any patient due to medical causes if deemed appropriate,
including patients that have undergone at least one (1) procedure.

Inclusion Criteria:

1. Subject is indicated for screening, diagnostic (minor complaints such as rectal
bleeding or minor abdominal pain) or surveillance colonoscopy

2. Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a
conventional colonoscope (including a single colon preparation bowel cleansing)

3. Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must
have a family history of a first degree relative with onset of colon cancer before the
age of 60).

4. Subject is able to understand and willing to sign informed consent form

Exclusion Criteria:

1. Personal history of colorectal neoplasia including familial adenomatous polyposis or
hereditary nonpolyposis, colon cancer (HNPCC).

2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or
Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe
diverticulosis, fecal incontinence or any known large-bowel disease that would require
a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or
non-surveillance cases)

3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance
of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or
non-surveillance cases)

4. History of colonic resection

5. Clinically significant cardiovascular or pulmonary disease.

6. Cancer or other life threatening disease or significant chronic condition that puts
the subject at risk.

7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to
100mg aspirin for prophylactic treatment are acceptable for this study)

8. Pregnancy

9. Previous radiation therapy to the abdomen

10. Morbid Obesity (BMI > 40 kg/m2)

11. Drug abuse or alcoholism

12. Subject is bed-ridden and/or unable to adequately communicate

13. Subject is under custodial care

14. Subject has a history of psychiatric disorders which would prevent compliance with
study instructions

15. Participation in a clinical study within the previous 30 days