Validation of Aer-O-Scope Colonoscope System Cecal Intubation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Aer-O-Scope Validation of Cecal Intubation
研究概览
简要总结
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Aer-O-Scope Validation of Cecal Intubation
时间窗: 30 minutes
The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope
次要结局
未报告次要终点