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First U.S. PillCam COLON Study Results Revealed

by Barbara Kram, Editor | October 24, 2006

The initial 44 subjects enrolled in the study received a single oral "booster" dose of sodium phosphate. The PillCam COLON capsule was excreted within 10 hours in 70% of the patients and reached various parts of colon in the other 30%. An additional dose of oral sodium phosphate was added to the regimen of the final 46 subjects to improve the capsule excretion rate. The PillCam COLON capsule in these patients was excreted within 10 hours in 78% of the patients and reached the rectosigmoid colon in the other 22%. Study investigators concluded that further improvements in the procedure will probably increase capsule examination completion and polyp detection rates.

PillCam SB

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"Capsule Endoscopy in Patients with Known IBD: Frequency of Findings, and Influence on Medical and Surgical Management are based on the indication for CE"

Researchers at Mount Sinai Medical Center led by Stephanie Santos, M.D., conducted a study to determine how often PillCam SB identifies significant findings in inflammatory bowel disease (IBD) patients and whether those findings impacted the management of these patients. Sixty-nine (69) patients were grouped into one of three categories based on their indication for capsule endoscopy: Indeterminate colitis to rule out small bowel disease (IC), known Crohn's disease with unexplained symptoms (CD-Sx) or known Crohn's disease with obscure bleeding (CD-OB). The investigators concluded that PillCam SB findings and the associated changes in management were significantly more common in patients with known Crohn's disease with unexplained symptoms, or obscure bleeding, than in patients with indeterminate colitis. Overall PillCam SB led to a change in management in the majority of patients 59% (n=41), supporting its use in patients with IBD.

"Development and Validation of a Capsule Endoscopy Scoring Index for Small Bowel Mucosal Disease Activity: The Lewis Score"

A team of seven investigators sought to develop and validate a simple, user-friendly PillCam capsule endoscopy scoring index to measure small bowel mucosal disease activity. Over a two year period, seven endoscopic variables were developed and evaluated including erythema; edema; nodularity, villous appearance; denuded mucosa, ulceration and stenosis. Additional index parameters measured include the number of lesions, the longitudinal extent of the disease, and ulcer shape and size. Based on a prospective review of forty (40) full length PillCam SB videos and ten (10) thumbnailed studies, the investigators concluded that the scoring index should include three variables; villous edema, ulceration and stenosis. The study also concluded that The Lewis Capsule Endoscopy scoring index may prove useful in measuring small bowel mucosal disease activity and serve as an objective scoring metric to measure small bowel disease states.