Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Muenster, 독일, 48149
- University of Muenster, Dept. of Medicine B
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Exclusion Criteria:
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
- Patient is pregnant
- Patient has had prior abdominal surgery of the GI tract
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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UC
Patients with known ulcerative colitis
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PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends.
It is 31.11
mm in size and takes pictures at a rate of 4 frames per second.
The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
Standard Colonoscopy: Pts.
undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
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a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tobias Meister, MD, University of Muenster, Dept. of Medicine B
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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