Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure|
- Colon cleansing level score for PCCE [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
- Grading of visual interference from bubbles in the colon for PCCE [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
- Number of colon capsules excreted over time [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
- Capsule transit time from ingestion to entrance into the cecum & through the colon [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
- Number, type and severity of adverse events [ Time Frame: WithIn 7 days ] [ Designated as safety issue: No ]
- Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 10mm as compared to colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Accuracy parameters (sensitivity, specificity ,NPV,PPV,LR) of PCCE in detecting polyps equal to or larger than 6mm as compared to colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- The diagnostic yield of PCCE in detecting a variety of colonic lesions [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.
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.
|United States, Indiana|
|University of Indiana Hospital|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Digestive Care Inc.|
|Beavercreek, Ohio, United States, 45440|
|United States, Virginia|
|Gastroenterology Associates of Tidewater|
|Chesapeake, Virginia, United States, 23320|
|Principal Investigator:||Douglas Rex, Dr||University of Indiana Hospital|
|Principal Investigator:||Douglas Morgan, Dr||University of North Carolina|