Bowel Diseases Clinical Trial
Official title:
Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure
The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.
The evaluation of subjects with suspected colonic disease includes endoscopic imaging by
colonoscopy and radiologic imaging such as air-contrast barium enema, or CT colonography. The
PillCam® platform offers an alternative approach for endoscopic visualization of the colon
using capsule endoscopy, an ingestible device which contains imagers, light sources, a power
source and a radio frequency transmitter. Advantages of the PillCam® platform include the
elimination of the need for 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 patients and thereby improving compliance 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 700,000 people worldwide
and is well accepted by patients and physicians as well as the major gastrointestinal
professional organizations. 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 specifically
designed capsule colonoscopy procedure allows for more efficient evaluation of the colonic
mucosa. This is expected to improve the capability of the PillCam® platform to detect colonic
pathologies and to serve as a diagnostic and screening tool for colonic disease. Further
details of the PillCam™ Colon Capsule Endoscope (PCCE) can be found in the device description
section.
This is a pilot study that is designed to develop the optimal PCCE procedure by measuring the
levels of cleanliness and capsule excretion rates. Furthermore, capsule endoscopy and
colonoscopy procedures will be compared in regards to the detection of polyps and lesions in
the colon.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00884624 -
Evaluation of the PillCam™ Colon Capsule -2 System
|
||
| 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
|
N/A |