A Prospective Trial of Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
研究概览
简要总结
The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.
详细描述
Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking adult patients (>18 years old) with known Crohn's disease
排除标准
- •Severe medical or psychiatric co-morbidities
- •Active swallowing problems
- •Bowel obstruction
- •History of stricture or fistula
- •Pregnancy
- •Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy
- •Inability to consent
- •Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease
结局指标
主要结局
Compare capsule endoscopy (CE) finding with traditional findings (colonoscopy and small-bowel follow through [SBFT]) in patients with known Crohn's disease
次要结局
- Evaluate the extent and severity of CE determined small-bowel involvement in patients with known Crohn's disease