NCT01787825已完成不适用
Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease
Capso Vision, Inc.14 个研究点 分布在 2 个国家目标入组 121 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 14
- 主要终点
- Normal vs Abnormal, Overall Impression
研究概览
简要总结
The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.
详细描述
This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 to 85 years of age (inclusive).
- •Willing and able to provide written informed consent.
- •Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease [should have had patency capsule, CT or MR enterography before entry], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome.
- •If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values <31% in males or <28% in females.
排除标准
- •Subjects who had a prior negative capsule endoscopy (within 1 year of study).
- •Known or suspected obstruction or stricture unless patency capsule confirms patency.
- •Known or suspected gastrointestinal perforation.
- •Known or suspected small bowel diverticuli.
- •Known swallowing disorder or the inability or unwillingness to swallow pills.
- •Radiation or chemotherapy induced enteritis.
- •History of Zenker's or known duodenal or jejunal diverticula.
- •Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms
- •Subjects who are high risk for undergoing surgical interventions (i.e., to CONFIDENTIAL CapsoVision Protocol SV-1 Revision: October 17, 2011 7 remove the capsule when capsule retention occurs).
- •Subjects with DNR/DNI "do not resuscitate/do not intubate" status.
- •Known or suspected gastrointestinal dysmotility.
- •Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant.
- •History of skin reaction to adhesives.
- •Subjects who in the Investigator's opinion should not consume the 2L GoLytely and 10 mg bisacodyl study drugs, because it could pose a significant additional risk to the subject because of the subject's medical condition.
- •Subjects who are scheduled for an MRI within 30 days of the last study visit.
- •Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening.
- •Mental and/or physical condition precluding compliance with the study and/or device instructions.
- •Participation in another clinical study within past 30 days.
结局指标
主要结局
Normal vs Abnormal, Overall Impression
时间窗: Study Completion
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
次要结局
- Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2(Study Completion)
- Preference Between CapsoCam SV-1 and PillCam SB2(Study Completion)
- Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2(Study Completion)
研究者
研究点 (14)
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