NL-OMON53838招募中不适用
Validation of an Intestinal Ultrasound Score Evaluating Inflammation and Treatment Response in Crohn*s Disease (USE-IT): A Prospective Multicenter Study. - USE-IT
International Bowel Ultrasound Group (IBUS)0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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
- •1. Confirmed diagnosis of CD according to standard clinical, endoscopic, and
- •histologic criteria of at least 3 months duration
- •2. Adults 18 years of age or older
- •3. Moderate to severely active CD defined by:
- •a. Active symptoms with an HBI score >= 5, and
- •b. Bowel wall inflammation defined as bowel wall thickness (BWT) > 3 mm in at
- •least 1 segment of the ileum or colon as determined by IUS
- •4. Patients with planned introduction of an SOC biologic and/or JAK inhibitor
- •therapy approved for CD as per their treating gastroenterologist to treat
- •active disease
- •5. Written informed consent must be obtained and documented
排除标准
- •1. Patients with a primary diagnosis of ulcerative colitis or IBD type
- •unclassified
- •2. Patients with prior intestinal surgery
- •3. Disease-related structural bowel complications as defined by CONSTRICT
- •a. Localized luminal narrowing (luminal diameter reduction of at least 50%
- •relative to normal adjacent bowel loop), and
- •b. Bowel wall thickening (25% increase relative to adjacent unaffected bowel),
- •c. Either: maximum associated small bowel dilation (luminal diameter greater
- •than or equal to 3 cm) OR inability to pass an adult or pediatric colonoscope
- •through the narrowed area prior to dilation and unequivocal proximal small
- •bowel dilation (but may be less than 3 cm). Endoscopic diagnosis of stricture
- •should be within 6 months of MRE
- •4. Disease-related penetrating complications (excluding perianal fistulizing
- •disease; patients with perianal disease are eligible if there is additional
- •inflammation in another bowel segment [other than the rectum])
- •5. Contraindication to IC or MRE
- •6. BMI greater than 35 at time of screening or other characteristics considered
- •likely to preclude IUS visualization of all bowel segments
- •7. Disease limited to the rectum
- •8. Serious underlying disease other than CD that in the opinion of the
- •investigator may interfere with the participant*s ability to participate fully
- •in the study
- •9. History of alcohol or drug abuse that in the opinion of the investigator may
- •interfere with the participant*s ability to comply with the study procedures
- •10. Pregnancy and female patients of child-bearing potential planning a
- •pregnancy during the study period
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