Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 16
- 主要终点
- Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
研究概览
简要总结
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
详细描述
This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .
Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ages 2-75 years, inclusive
- •Subjects with a diagnosis of known Crohn disease
- •Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)
- •Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.
- •Subject or parent agrees to sign consent form
排除标准
- •The presence of any of the following will exclude a subject from study enrollment:
- •Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE
- •Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
- •Stricture seen on radiological exam.
- •Indeterminate Colitis
- •Ulcerative Colitis
- •Antibiotic Associated Colitis
- •Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
- •Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
- •Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
- •Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- •Subjects with known or suspected delayed gastric emptying
- •Subjects with known or suspected delayed Small bowel motility
- •Subject has any allergy or other known contraindication to the medications used in the study.
- •Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
- •Unwillingness to use a medically accepted method of contraception throughout duration of study
- •Concurrent participation in another clinical trial using any investigational drug or device.
- •Subject has cardiac pacemaker or other implanted electromedical devices
- •Subject suffers from a life threatening condition.
- •Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
- •Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
结局指标
主要结局
Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)
时间窗: 6 months changefrom Baseline
To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff
次要结局
- Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes(Baseline)
- Evaluate the Entire SB CE Scores(6 months change from Baseline)
- Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum(6 months change from Baseline)
- Adverse Events (AE)(6 months)