A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Ability to traverse the colon using the aer-o-scope
研究概览
简要总结
A single center study intended to evaluate the Aer-O-Scope Colonoscope System.
详细描述
A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints:
Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon.
Safety: No occurrence of any device related major adverse event (for details see section 9.5)
Efficacy:
- Advancement of device towards the ceacum and retraction
- Visualization of the colon mucosa by the traveling imaging device
- Procedure duration
- Handling and operation (assessment by operator)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 18 and 65 years of age.
- •Sign informed consent.
排除标准
- •Subjects with any known GI related symptoms complaints or GI diseases.
- •Subjects with cancer or other life threatening diseases or conditions.
- •Pregnant women.
- •Subjects who underwent any abdominal surgery.
- •Morbid Obesity (BMI > 40).
- •Drug abuse or alcoholism.
- •Bed-ridden subject.
- •Inadequate communication with the subject.
- •Subjects under custodial care.
- •Participation in any clinical study within the last 30 days.
- •Subjects with known cardiovascular and pulmonary diseases.
研究组 & 干预措施
single arm
single arm patients underwent colonoscopy with aer-o-scope followed by conventional colonoscopy to assess if any mucosal damage occurred with the experimental device.
干预措施: screening colonoscopy (Biological)
结局指标
主要结局
Ability to traverse the colon using the aer-o-scope
时间窗: under 60 minutes
a propulsion system using low pressure co2 gas and balloons is used to propel the system through the colon
次要结局
未报告次要终点