Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
연구 개요
상세 설명
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
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic Arizona
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55446
- Minnesota Gastroenterology
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Rochester
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New York
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New York, New York, 미국, 10128
- Private Medical Facility
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Oregon
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Portland, Oregon, 미국, 97239-3098
- Oregon Health Sciences University
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Haifa, 이스라엘
- Rambam Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 시간 관점: 유망한
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Douglas Rex, M.D., Indiana University Hospital
- 수석 연구원: Glenn Eisen, M.D., Oregon Health and Science University
- 수석 연구원: Chris Gostout, MD, Mayo Clinic
- 수석 연구원: Blair Lewis, MD, Private Medical Facility
- 수석 연구원: S Ketover, MD, Minnesota Gastroenterology
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MA-54
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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