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Sponsored by: |
Given Imaging Ltd. |
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Information provided by: | Given Imaging Ltd. |
ClinicalTrials.gov Identifier: | NCT00604422 |
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis
Condition |
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Colonic Disease Ulcerative Colitis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in Detection & Classification of Ulcerative Colitis |
Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Groups/Cohorts |
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A
Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease
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Ulcerative colitis (UC) is a disorder of unknown origin that may be characterized by acute and chronic inflammation of the colon. The extent of the colonic mucosal inflammation varies among individuals, but the disease almost always involves the rectum. Ulcerative colitis has required evaluation by colonoscopy to determine the extent and severity of the disease. The PillCam platform 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 PillCam platform 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 . Furthermore, compared to standard colonoscopy, the PillCam platform may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon. The PillCam® SB capsule (formerly M2A® Capsule) that was FDA-approved 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 professional societies. 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 dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. Further details of the PillCam® Colon Capsule Endoscope (PCCE) can be found in the device description section.
In previous studies, the PillCam colon platform has been shown to be safe and to be able to demonstrate colon polyps and cancers. This study is an extension to a trial evaluating the use of PCCE in ulcerative colitis that has already been completed in Hong Kong (n=40). This study is designed to assess the ability of the capsule to accurately detect inflammatory lesions and thus classifying the extent and severity of disease in subjects with ulcerative colitis in comparison to traditional colonoscopy.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease
The study population will consist of subjects who fulfill all the inclusion criteria and none of the exclusion criteria.
Inclusion Criteria:
Exclusion Criteria:
Hong Kong | |
Chinese university of Hong Kong, Princes of Walses Hospital | |
Hong Kong, Hong Kong | |
Singapore | |
Department of Medicine, National University Hospital | |
Singapore, Singapore, 119074 | |
Taiwan | |
Department of Internal Medicine & Health Management Center, National Taiwan University Hospital | |
Taipei, Taiwan |
Principal Investigator: | Josef Sung, Prof. | Chinese University of Hong Kong |
Responsible Party: | Given Imaging Ltd. ( Hilla Debby- Corp.Clinical Affairs for Colon Products ) |
Study ID Numbers: | MA-107 |
Study First Received: | January 24, 2008 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00604422 History of Changes |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Colonic disease Ulcerative colitis suspected or known colonic disease |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |