NCT00867724已完成不适用
A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
GI View Ltd.1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ability to screen the entire length of the colon to the cecum.
研究概览
简要总结
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
详细描述
Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients between 18 and 70 years of age
- •Patients who are generally healthy and classified as low risk for CRC
- •Patients who are ready to undergo standard colonoscopy examination including colon prep.
- •Signed informed consent
排除标准
- •Patients with any known GI related symptoms complaints or GI diseases
- •Patients with cancer or other life threatening diseases or conditions
- •Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
- •Pregnant women
- •Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
- •Morbid Obesity (BMI > 40)
- •Drug abuse or alcoholism
- •Bed-ridden patient
- •Inadequate communication with the patient
- •Patients under custodial care
- •Participation in current clinical study or clinical study within 30 days prior to the procedure
结局指标
主要结局
Ability to screen the entire length of the colon to the cecum.
时间窗: 30 -60 minutes
次要结局
- Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events(24 hours)
研究者
研究点 (1)
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