Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Study Overview
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Brief Summary
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61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation

Detailed Description
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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.

Official Title
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Validation of Aer-O-Scope Colonoscope System Cecal Intubation

Conditions
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Colonic Polyp, Colonic Neoplasms, Colonic Diseases, Colon Adenoma, Colon Disease, Colon Adenocarcinoma, Colon Cancer

Intervention / Treatment
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* Device: Aer-O-Scope Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy Subject willing to undergo colon preparation bowel cleansing 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). Subject is able to understand and willing to sign informed consent form Exclusion Criteria: Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC). 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) Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) History of colonic resection Clinically significant cardiovascular or pulmonary disease. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study) Pregnancy Previous radiation therapy to the abdomen Morbid Obesity (BMI > 40 kg/m2) Drug abuse or alcoholism Subject is bed-ridden and/or unable to adequately communicate Subject is under custodial care Subject has a history of psychiatric disorders which would prevent compliance with study instructions Participation in a clinical study within the previous 30 days

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Cohort<br>61 subjects will undergo colonoscopy | Device: Aer-O-Scope Colonoscopy<br>* resection or biopsy of colonic abnormalities for histopathalogical evaluation<br>* Other names: therapeutic intervention - polyp resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aer-O-Scope Validation of Cecal Intubation | The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening-colonoscopy, diagnostic-colonoscopy, surveillance-colonoscopy