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- Secondary Analysis by Dr. Rex of sub-set of PillCam COLON trial data shows sensitivity for detecting adenomas that are at least 6 mm and 10 mm to be 88% and 92% respectively and specificity to be 82% and 95% respectively -
- Additional study also validates using PillCam COLON as a useful tool for GI physicians for patients with incomplete colonoscopies -
ORLANDO, Fla., May 21, 2013 (GLOBE NEWSWIRE) -- Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced a secondary analysis of data from its prospective, multicenter clinical trial to assess the accuracy and safety of PillCam COLON for detecting lesions at least 6 mm in size.
Douglas Rex, M.D., Distinguished Professor of Medicine and Chancellor's Professor, Indiana University School of Medicine and Director of Endoscopy, Indiana University Hospital and PillCam COLON pivotal trial lead investigator, presented these data at a podium presentation today at Digestive Disease Week
® (DDW) taking place May 18 - 21, 2013 here at the Orange County Convention Center.
"Detecting adenomas is one of the highest clinical priorities in evaluating patients as 65% to 70% of colorectal cancers develop from adenomas. To this end, I am encouraged by the results of this analysis, especially the sensitivity for detecting adenomas. They show that PillCam COLON may be an appropriate tool to help physicians identify adenomas in patients who cannot undergo colonoscopy," said Dr. Rex. "Among the most utilized alternatives to colonoscopy available, most involve radiation. Data from this study appear to clinically validate PillCam COLON as an adequate, minimally invasive, radiation-free and a patient-friendly option for gastroenterologists to provide optimal care for patients."
Dr. Rex presented data from the 16-site study,
podium presentation 907, Accuracy of PillCam Colon 2 for Detecting Subjects with Adenomas ≥ 6 mm. Overall, 884 patients at average risk for colon cancer as defined by the U.S. Multi-Society Task Force guidelines on colorectal cancer screening were enrolled into the pivotal study. Following bowel prep, the patients visited the investigator's office in the morning and ingested a PillCam COLON capsule endoscope, which transmitted images to a wireless recorder worn by patients as they went about their daily routine for up to 12 hours. The resulting video sequences were stored and saved until after the patients had a traditional optical colonoscopy four to six weeks later. The capsule results were unblinded and reviewed after the traditional colonoscopy was performed and then the two video sequences were compared with the goal of identifying all polyps that were at least 6 mm and then those at least 10 mm. When doctors found evidence of a polyp on the PillCam COLON sequences that they didn't see during the colonoscopy, a follow-up colonoscopy was performed to confirm or rule out the capsule finding.
The data analysis applied to the subset of subjects showed PillCam COLON had 88% sensitivity and 82% specificity in detecting adenomas at least 6 mm in size and 92% sensitivity and 95% specificity in detecting adenomas at least 10 mm in size. These data provide preliminary evidence that PillCam COLON approaches the effectiveness of optical colonoscopy to detect conventional adenomas and, like colonoscopy, provides direct visualization of the entire colon mucosa. This data is not included in the proposed FDA labeling for the PillCam COLON capsule now under review at the agency.