EUCTR2015-002882-41-AT进行中（未招募）不适用
Sono-Response-StudyA Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease
Medical University of Vienna (MUW)0 个研究点开始时间: 2015年11月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Men and women above the age of 18 with an established diagnosis of Crohn’s disease for at least 3
- •months (according to a histology from an ileocolonoscopy evidentiary
- •for Crohn’s disease)
- •2) Able and willing to provide written informed consent
- •3) Crohn’s disease with evidence
- •of ileal or ileocolonic disease
- •4) Clinically active disease as evidenced by a Harvey Bradshaw index of 8 or above
- •5) Planned step--up in immunosuppressive therapy with an antiTNFalpha agent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1) Ulcerative colitis or indeterminate colitis
- •2) Isolated colonic Crohn’s disease
- •3) Contraindications for undergoing magnetic resonance imaging with computed tomography or other methods planned to be applied for disease/response assessment as substitute for MRI
- •4) Contraindications to undergo contrast enhanced ultrasound examinations
- •5) Contraindications against therapy with an antiTNFalpha agent
- •6) Inability to adhere to follow up schedule and/or provide information necessary to assess response parameters
- •7) Unwilling or unable to undergo blood sampling
- •8) Female subjects pregnant or planning pregnancy within the timeframe of the study participation
- •9) Significant coronary heart disease, right-to-left, bidirectional, or transient right-to-left cardiac shunt
研究者
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