Comparison Study of IntroMedic®'s MiroCam® and Olympus®' Enteropro EndoCapsule®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total video length
研究概览
简要总结
MiroCam® is the new video capsule endoscope of IntroMedic®. By using a novel transmission technology it promises a longer battery life expectancy with consequential impact on the length of the video recorded for diagnostic evaluation. As the investigators know about the shortcoming of battery life expectancy from many capsule examinations that were inconclusive because the ileocaecal transit was not filmed, the investigators would appreciate to have a capsule with extended video recording to improve the diagnostic yield of capsule examinations. Therefore the investigators want to compare MiroCam® to our routinely used Olympus® Enteropro EndoCapsule® in the context of a half-year clinical trial. Focussing on the total video length as well as on the rate of video-recorded ileocaecal transitions as surrogate parameters the investigators want to find out whether one of the two products provides superior diagnostic information in order to reduce the amount of inconclusive examinations.
详细描述
Introduction
Video capsule endoscopy (VCE) is an important tool in the diagnostic management of several gastrointestinal (GI) disorders. Taking a video while passing the GI tract, VCE is the only technique providing image information of the whole small bowel. It is a comfortable and safe procedure; complications due to capsule retention are rare [1]. The main disadvantage of VCE is made up by its only dependence on macroscopic information. Therefore it can not be reliably used for the detection of disorders that need histological confirmation. However, lots of macroscopic pathologies can be diagnosed or excluded by VCE. Above all, obscure digestive bleeding (ODB) has become the main indication for the use of VCE [2].
Independent from the type of bowel preparation used, the ileocaecal transit cannot be visualized in up to 20 percent of VCE examinations, which means the loss of diagnostic information of the last intestinal parts [3]. Risk factors of such incomplete VCE include previous small-bowel surgery, hospitalization, moderate or poor bowel cleansing and a gastric transit time longer than 45 minutes [4]. Especially in the latter case, the success of the examination is determined by the battery life expectancy of the capsule technology used [5].
The new MiroCam®, a brand of IntroMedic®, is advertised to have a longer battery life expectancy than competitive products throughout the market. To prove this pronouncement, a pilot-study of 16 patients was presented by He Man Kim at the UEGW 2008, comparing MiroCam® to Given®'s PillCam® by sequential application of both capsules. Although the battery life expectancy of MiroCam® was significantly higher, there was no significant difference in the diagnostic yield of both products [6]. Currently a similar comparison study between MiroCam® and Pill Cam® is ongoing in France, involving a higher amount of patients [unpublished data].
Study Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Patients transferred to our unit to undergo video capsule endoscopy because of
- •Obscure digestive bleeding (ODB)
- •Chronic anaemia of unknown origin
- •Chronic diarrhoea
排除标准
- •Patients age below 18 years
- •Patients presenting with contraindications to video capsule endoscopy which are already known gastrointestinal stenoses, already known gastrointestinal adhesions, already known diverticula of the small bowel, already known severe or diabetes induced intestinal hypomotility
- •Refusal to participate in the study
结局指标
主要结局
Total video length
时间窗: 6 months
The primary endpoint will be the total video length registered as well as the rate of successful ileocoecal transitions during ongoing video registration.
次要结局
- Diagnostic yield(6 months)
研究者
Werner Dolak, MD
Principal Investigator
Medical University of Vienna
