2023-508500-38-00尚未招募2 期
Sonographic Diagnostics with Oral Contrast for Crohn’s disease 2. A novel method for detecting Crohns disease using sonographic intraluminal contrast
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of patients with homogenous contrast filling of the entire lumen of the terminal ileum within 1 hours of ingestion, with a clear separation between the lumen and intestinal wall as visually assessed by the examiner.
研究概览
简要总结
Develop a method for investigating the small bowel in Crohn’s disease using transabdominal ultrasound and microbubbles as luminal contrast.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Assessment period
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old with Crohn’s disease in the terminal ileum who undergo ileocolonoscopy
- •Healthy volunteers > 18 years without known gastrointestinal illnesses
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Age<18 years
- •Known egg allergy
- •Breastfeeding
- •Severe obesity (BMI >35)
- •Serious heart or lung disease
- •Change in treatment for Crohn’s disease between endoscopy/ultrasound and contrast ultrasound examination
结局指标
主要结局
Number of patients with homogenous contrast filling of the entire lumen of the terminal ileum within 1 hours of ingestion, with a clear separation between the lumen and intestinal wall as visually assessed by the examiner.
Number of patients with homogenous contrast filling of the entire lumen of the terminal ileum within 1 hours of ingestion, with a clear separation between the lumen and intestinal wall as visually assessed by the examiner.
次要结局
- Number of patients who develop adverse events and severe adverse events
- Number of patients who are willing to undergo the procedure again
- Number of patients with detected stenosis in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy.
- Number of patients with detected ulcers >0,5cm in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy
- Number of patients with large (0,5cm-2cm) and very large (>2cm) ulcers in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy.
- Interobserver variability for wall thickness in the terminal ileum with and without contrast as visually assessed by the examiner.
- Number of patients with visible intestinal contractions with and without contrast
- Number of patients with ulcers and visible intestinal contractions in the terminal ileum
- Number of patients with stenosis and visible intestinal contractions in the terminal ileum
- The correlation between ulcer size, bowel wall thickness and frequency of contractions in the terminal ileum.
- The correlation of motility findings in Crohn’s patients and healthy volunteers
- The number of patients with detected disease activity in the neoterminal ileum with and without contrast.
研究者
Kim Nylund
Scientific
Helse Bergen HF
研究点 (1)
Loading locations...
相似试验
终止
4 期
Ultrasound Evaluation of Crohn's DiseaseCrohn DiseaseNCT03235180Mayo Clinic9
Unknown
不适用
Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel DiseaseInflammatory Bowel DiseaseNCT03744130State Scientific Centre of Coloproctology, Russian Federation200
已完成
不适用
ltrasound scanning with contrast enhancement to assess disease activity in Crohn's diseaseOral and Gastrointestinal - Crohn's diseaseCrohn's diseaseACTRN12609000323224Royal Perth Hospital30
已完成
不适用
Endomicroscopy and Crohn´s DiseaseCrohn´s DiseaseNCT01102855University of Erlangen-Nürnberg Medical School40
已完成
4 期
Adalimumab-psoriasis and Small Bowel LesionsCrohn's DiseasePlaque PsoriasisNCT01556672Innovaderm Research Inc.100