Bowel Diseases Clinical Trial
Official title:
Evaluation of the PillCam™ Colon Capsule -2 System
The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by
colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or
virtual colonoscopy.
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of
the colon. 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 . Furthermore, compared to
standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the
subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the
colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001
for small bowel evaluation has been ingested to date by more than 500,000 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. This is expected to improve the capability of the Given® Diagnostic System to
detect colonic pathologies and to serve as a diagnostic and screening tool for colonic
disease. To date, several clinical studies have been conducted with PillCam™ Colon Endoscope
1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily
aimed to increase sensitivity and specificity for polyp detection.
Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device
description section.
This study is designed to evaluate the performance of the new version of colon capsule and
its performance in detecting lesions in the colon as compared to conventional colonoscopy.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00885235 -
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
|
||
| Completed |
NCT01087528 -
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
|
N/A | |
| Completed |
NCT02848040 -
The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
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N/A |