Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The
 primary outcome is Cecal Intubation
This will be a prospective single-center non-blinded clinical investigation. Each subject
 will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All
 pathologies found will be removed. No control group is necessary as the main objective is to
 reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy
 procedures.

 Up to the first ten (10) cases for each physician will be system operation training cases.

 The primary endpoint of cecal intubation was chosen as this measure is the first quality
 objective when evaluating colonoscopy quality indicators.
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 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