Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Gentle Colonoscopy
- 发起方
- Invendo Medical GmbH
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- 1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
- 状态
- 终止
- 最后更新
- 11年前
概览
简要总结
The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.
详细描述
The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points: 1. The diagnostic performance of the device including polyp and adenoma detection rates; 2. The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions); 3. Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).
研究者
入排标准
入选标准
- •Any indication for colonoscopy
- •Willing to give informed consent
- •Willing to consume 2-4 liters of bowel prep
排除标准
- •An age younger than 18 years
- •Congestive heart failure
- •Renal insufficiency
- •Intestinal obstruction
- •Any acute life-threatening condition (in the opinion of the investigator)
- •Current pregnancy
- •Abdominal surgery in the past 6 months
- •Bleeding disorders
- •Inability to provide informed consent
- •Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)
结局指标
主要结局
1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
时间窗: average 6 to 12 months
次要结局
- 2. Detection of polyps, adenomas and other lesions in all individuals(average 6 to 12 months)