NCT06065228招募中不适用
Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary objective of this study is the measurement of the nociceptive index for clinical output.
研究概览
简要总结
The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 6 years of age at screening.
- •Documentation of an IBD diagnosis as evidenced by history
排除标准
- •Documented history of eye disease precluding pupillometry
- •Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.
研究组 & 干预措施
UC
干预措施: AlgometRx Nociometer (Device)
CD
干预措施: AlgometRx Nociometer (Device)
结局指标
主要结局
The primary objective of this study is the measurement of the nociceptive index for clinical output.
时间窗: 1 Year
次要结局
- The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions.(1 Year)
研究者
Julia Finkel
Professor of Anesthesiology and Pediatrics
Children's National Research Institute
研究点 (2)
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