An observational study in Colonic Disease and Ulcerative Colitis, sponsored by Medtronic - MITG. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Medtronic - MITG · Observational
To evaluate the ability of the PillCam® Colon Capsule Endoscope to detect and classify Ulcerative colitis
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 97 is close to the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
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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.
Exclusion Criteria:
Subjects that are indicated for standard colonoscopy due to suspected or known Ulcerative colitis disease
Agreement level between capsule and colonoscopy in classifying colitis into the above (see section 3.1) categories.
Time frame: within 7 days
Number, type and severity of adverse events with both PCCE and standard colonoscopy
Time frame: Within 7 days
Accuracy parameters for detecting active UC
Time frame: within 7 days
Disease severity scoring index for both PCCE and .standard colonoscopy
Time frame: within 7 days
Colon cleansing level score for both PCCE and standard colonoscopy.
Time frame: within 7 days
Grading of the bubbles interference at the colon for PCCE.
Time frame: Within 7 days
Percentage of excreted colon capsules
Time frame: Within 7 Days
PCCE transit time from ingestion to excretion and colon transit time
Time frame: Within 7 Days
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG