Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Aer-O-Scope Validation of Cecal Intubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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
Outcomes
Primary Outcomes
Aer-O-Scope Validation of Cecal Intubation
Time Frame: 30 minutes
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
Secondary Outcomes
No secondary outcomes reported