Colon Adenocarcinoma, Colon Adenoma, Colon Cancer, Colon Disease, Colonic Diseases, Colonic Neoplasms, Colonic Polyp
Conditions
Keywords
screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy
Brief summary
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Detailed description
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.
Interventions
DEVICEAer-O-Scope Colonoscopy
resection or biopsy of colonic abnormalities for histopathalogical evaluation
Sponsors
GI View Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aer-O-Scope Validation of Cecal Intubation | 30 minutes | The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope |
Countries
Israel
Outcome results
None listed