Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
研究概览
详细说明
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects will participate in this study. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.
Each subject will undergo PCCE. All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians. All readers, experienced in PillCam SB, will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos. Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE. PCCE results will be compared with that of a colonoscopy procedure.
Following PCCE procedure, standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE. The colonoscopist will be "unblinded" during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope.
Primary Endpoint - Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy.
• Number, type and severity of adverse events with both PCCE and standard colonoscopy
研究类型
注册 (实际的)
联系人和位置
学习地点
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Haifa、以色列
- Rambam Medical Center
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Arizona
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Scottsdale、Arizona、美国、85259
- Mayo Clinic Arizona
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University Hospital
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Minnesota
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Minneapolis、Minnesota、美国、55446
- Minnesota Gastroenterology
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Rochester、Minnesota、美国、55905
- Mayo Clinic Rochester
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New York
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New York、New York、美国、10128
- Private Medical Facility
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Oregon
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Portland、Oregon、美国、97239-3098
- Oregon Health Sciences University
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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
描述
Inclusion criteria:
Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
Subject was referred for standard colonoscopy for one of the following reasons:
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
• Any subject over 18 years of age with:
- Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
- Suspected or known ulcerative colitis
Exclusion criteria
The presence of any of the following will exclude a subject from study enrollment:
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Subject has a cardiac pacemaker or other implanted electro medical devices.
- Subject is pregnant
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- 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 any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
学习计划
研究是如何设计的？
设计细节
- 时间观点：预期
合作者和调查者
调查人员
- 首席研究员：Douglas Rex, M.D.、Indiana University Hospital
- 首席研究员：Glenn Eisen, M.D.、Oregon Health and Science University
- 首席研究员：Chris Gostout, MD、Mayo Clinic
- 首席研究员：Blair Lewis, MD、Private Medical Facility
- 首席研究员：S Ketover, MD、Minnesota Gastroenterology
研究记录日期
研究主要日期
学习开始
初级完成
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
与本研究相关的术语
其他研究编号
- MA-54
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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