NL-OMON50462已完成不适用
ASSESSMENT OF THE PERFORMANCE OF THE SECOND GENERATION PILLCAM COLON CAPSULE (PCCE 2) IN CROHN*S DISEASE, BEFORE AND AFTER TREATMENT WITH ANTI-TNF AGENTS OR VEDOLIZUMAB : SENSITIVITY TO CHANGE STUDY - STOC study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Active ileocolonic Crohn's disease with CDAI > 150
- •Elevated faecal calprotectin >250 ug/g and /or increased CRP levels(>5mg/l)
- •and/ or endoscopy showing ulcerations <3 months prior to screening without any
- •change in treatment, regardless of biomarkers.
- •Abdominal imaging clinically indicated in order to determine disease activity
- •before embarking on anti-TNF or vedolizumab treatment
排除标准
- •Any contraindication for colon capsule examination including swallowing
- •disorders, severe congestive heart failure, renal insufficiency or co-morbities
- •contraindicating these procedures.
- •More than 1 bowel resection for CD
- •Previous subtotal or total colectomy
- •Active (draining) fistulas
- •Known small bowel strictures
- •Short bowel syndrome or stoma
- •High suspicion of small bowel strictures.
- •Pacemaker or ICD
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