Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure
研究概览
地位
条件
详细说明
The evaluation of subjects with suspected colonic disease includes endoscopic imaging by colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The PillCam® platform offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, an ingestible device which contains imagers, light sources, a power source and a radio frequency transmitter. Advantages of the PillCam® platform include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the PillCam® platform may be more readily accepted by patients and thereby improving compliance with colorectal cancer screening recommendations.
The PillCam® SB capsule (formerly M2A® Capsule) that was cleared by the FDA in August 2001 for small bowel evaluation has been ingested to date by more than 700,000 people worldwide and is well accepted by patients and physicians as well as the major gastrointestinal professional organizations. However, adequate visualization of the colon cannot be achieved with the standard PillCam®SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam® SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam® SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a specifically designed capsule colonoscopy procedure allows for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the PillCam® platform to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. Further details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description section.
This is a pilot study that is designed to develop the optimal PCCE procedure by measuring the levels of cleanliness and capsule excretion rates. Furthermore, capsule endoscopy and colonoscopy procedures will be compared in regards to the detection of polyps and lesions in the colon.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- University of Indiana Hospital
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina
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Ohio
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Beavercreek、Ohio、美国、45440
- Digestive Care Inc.
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Virginia
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Chesapeake、Virginia、美国、23320
- Gastroenterology Associates of Tidewater
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.
The study population will consist of subjects who fulfill at least one of the inclusion criteria and none of the exclusion criteria.
描述
Inclusion Criteria:
- Subjects over ≥ 50 years of age scheduled for colorectal cancer screening
- Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
Subject ≥ 18 years of age with one of the following:
- Positive findings (≥ 10 mm polyps) in the colon on a GI radiographic study (BE, CT scan, etc) OR
- Personal history of colorectal cancer (CRC) or adenomatous polyps and ≥5 years since last colonoscopy
Exclusion Criteria:
- Subject has dysphagia or any swallowing disorder
- Subject has congestive heart failure
- Patient has significant renal insufficiency, heart disease or any other condition that the investigator would expect to increase the risk of complications from magnesium citrate, such as dehydration or electrolyte imbalance
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
- Subject with gastrointestinal motility disorders
- Subject has known delayed gastric emptying
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception such as: surgical sterilization, approved hormonal contraceptives (i.e. birth control pills, Depo-Provera), barrier methods (i.e. condom or diaphragm) used with a spermicide and an intrauterine device (IUD)
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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A
Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
不良事件的数量、类型和严重程度
大体时间:7天内
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7天内
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Colon cleansing level score for PCCE
大体时间:Within 7 days
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Within 7 days
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Grading of visual interference from bubbles in the colon for PCCE
大体时间:Within 7 days
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Within 7 days
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Number of colon capsules excreted over time
大体时间:Within 7 Days
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Within 7 Days
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Capsule transit time from ingestion to entrance into the cecum & through the colon
大体时间:Within 7 Days
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Within 7 Days
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次要结果测量
结果测量 |
大体时间 |
---|---|
Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 10mm as compared to colonoscopy
大体时间:within 7 days
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within 7 days
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Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 6mm as compared to colonoscopy
大体时间:within 7 days
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within 7 days
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The diagnostic yield of PCCE in detecting a variety of colonic lesions
大体时间:within 7 days
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within 7 days
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合作者和调查者
调查人员
- 首席研究员:Douglas Rex, Dr、University of Indiana Hospital
- 首席研究员:Douglas Morgan, Dr、University of North Carolina
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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