Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00885235|
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : August 4, 2009
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Evaluation of the PillCam Colon Capsule Endoscopy Preparation and Procedure|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||August 2009|
Subjects that are indicated for colonoscopy who are suspected or known to suffer from large bowel diseases.
- Colon cleansing level score for PCCE [ Time Frame: Within 7 days ]
- Grading of visual interference from bubbles in the colon for PCCE [ Time Frame: Within 7 days ]
- Number of colon capsules excreted over time [ Time Frame: Within 7 Days ]
- Capsule transit time from ingestion to entrance into the cecum & through the colon [ Time Frame: Within 7 Days ]
- Number, type and severity of adverse events [ Time Frame: WithIn 7 days ]
- 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 ]
- 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 ]
- The diagnostic yield of PCCE in detecting a variety of colonic lesions [ Time Frame: within 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885235
|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|