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Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
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 1,000,000 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 Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.
This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PillCam™ (Capsule Endoscopy) Colon 2 capsule
Hospital Erasme - Gastro-Enterologie
Given Imaging Ltd.
Published on BioPortfolio: 2014-08-27T03:16:08-0400
PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold sta...
The purpose of this study is to compare two preparation and procedure in order to develop the most optimal capsule procedure in regards to colon cleansing level and capsule excretion rate.
The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon cleansing level and capsule excretion rate.
Diagnostic yield of Small Bowel Capsule Endoscopy (SBCE) for the assessment of small bowel (SB) lesions is higher than radiologic imaging techniques. However, magnetic resonance enterography (MRE) dat...
The role of capsule endoscopy in established celiac disease remains unclear. Our objective was to analyse the usefulness of capsule endoscopy in the suspicion of complicated celiac disease.
Capsule endoscopy was used to detect intestinal infection in a 19-year-old man. The patient was initially believed to have Crohn's disease due to a notable family history of the disease. Capsule endo...
The usefulness of purgative preparation before small-bowel video capsule endoscopy is controversial. We aimed to examine the effect of purgative preparation on small-bowel video capsule endoscopy o...
To compare the findings and completion rate of PillCam® SB2 and SB3.
Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.
Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.
A pathological condition characterized by the presence of a number of COLONIC DIVERTICULA in the COLON. Its pathogenesis is multifactorial, including colon aging, motor dysfunction, increases in intraluminal pressure, and lack of dietary fibers.
A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.
The sac enclosing a joint. It is composed of an outer fibrous articular capsule and an inner SYNOVIAL MEMBRANE.
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...
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