Full article reprinted from 'The Gray Sheet" - July 20, 2009
Given Imaging expects its PillCam COLON 2 endoscopy capsule will overcome many of the limitations identified in a recent clinical trial comparing its first-generation PillCam COLON to standard colonoscopy. Find out more...
Full article reprinted from 'The Gray Sheet" - July 20, 2009
Given Imaging expects its PillCam COLON 2 endoscopy capsule will overcome many of the limitations identified in a recent clinical trial comparing its first-generation PillCam COLON to standard colonoscopy.
Given is currently finishing some R&D trials in Israel and plans to launch the next-generation device at the Gastro 2009 conference in London in November, Given CEO Homi Shamir told "The Gray Sheet." The Gastro meeting is sponsored by the United European Gastroenterology Federation.
Once PillCam COLON 2 is launched in Europe, the company expects to announce its plans for a U.S. clinical trial that will eventually support an FDA submission, Shamir said. The firm is currently in discussions with the agency about the design of the pivotal trial, but will not disclose any details yet.
The PillCam capsule endoscope is a miniaturized video camera contained in a disposable capsule that is ingested by the patient and delivers color video images of the inside of the gastrointestinal tract. Procedures with the technology require no sedation.
The first-generation PillCam COLON received a CE mark in 2006 and is available in Europe, Israel, Asia, Latin America, Canada and Australia.
FDA rejected the firm's 510(k) for the device in 2008, deeming it not substantially equivalent to any marketed device for visualization of the colon. The company says it is not planning to file another 510(k) or PMA for the first-generation PillCam COLON (1 'The Gray Sheet' Feb. 25, 2008).
FDA has cleared PillCam SB 2 for the small bowel and PillCam ESO 2 for the esophagus.
Potentially Large Market Awaits Device
FDA go-ahead for PillCam COLON2 could provide Given access to the potentially large market for alternatives to traditional colonoscopy.
According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed in the United States and the second leading cause of death from cancer. About 150,000 people are diagnosed with the disease and about one third of those die from it each year, although the five-year survival is about 90% if the disease is diagnosed while still localized.
Currently, optical colonoscopy is the standard procedure for colorectal cancer screening, but many people at risk for colon cancer avoid colonoscopy because it is inconvenient and uncomfortable.
Although the life-saving value of colorectal screening is well established in randomized trials and observational studies, a 2006 NIH study found that only about half of people 65 years and older underwent anyrecommended colorectal cancer test. Testing rates for people 50 to 64 were about 40% for men and about 30% for women.
According to Given, the colorectal cancer screening rate is below 10% in Europe, where about 250,000 people die from the disease annually.
The company believes that availability of a safe colonoscopy capsule as an alternative or complement to standard optical colonoscopy would increase patient compliance with colorectal cancer screening guidelines. Given is planning future studies to see if the availability of capsule endoscopy improves colorectal screening rates.
Shamir said an increase in the screening rate of just a few percentage points could make a significant difference in the colorectal cancer mortality rate.
PillCam Does Not Match Standard In Trial
The limitations of the current version of PillCam COLON were demonstrated in a study published in the July 16 New England Journal of Medicine by researchers at Erasme University Hospital, Brussels.
The Belgian study, which was supported by Given, randomized patients with known or suspected colonic disease to colon imaging with PillCam COLON or standard optical colonoscopy. Both imaging modalities are intended to detect polyps, advanced adenoma or cancer.
The sensitivity of the PillCam COLON test is calculated as the percentage of the patients who had a positive finding with the capsule endoscopy among those who had a positive finding with standard optical colonoscopy. The specificity of the PillCam COLON test is calculated as the percentage of patients who had negative findings with the capsule endoscopy among those who also had a negative finding with standard optical colonoscopy.
The sensitivity and specificity of capsule endoscopy for detecting polyps 6 mm in diameter or greater were 64% and 84%, respectively. For adenoma, the sensitivity and specificity were 73% and 79%, respectively. The PillCam COLON detected 14 of the 19 cancers that were found by optical colonoscopy.
PillCam COLON's sensitivity was higher in patients in whom pre-test cleaning of the colon with a polyethylene glycol and water solution was deemed good or excellent than in patients whose colon cleanliness was fair or poor.
Mild to moderate adverse events were found in 7.9% of patients, usually related to colon preparation.
Trial Shows Where Upgrades Are Needed
Although the Belgian study showed that colonoscopy with PillCam COLON was not as sensitive or specific as the standard, "the data show that this first-generation PillCam COLON is safe and can visualize the colon," co-primary investigator Jacques Devière, M.D., says in a Given release.
"We believe that with the scheduled upgrades in capsule technology in [COLON 2], more efficient colon preparation and higher rates of adequate colon cleansing among patients, PillCam COLON could be a promising new tool to complement colonoscopy for detection of polyps and diagnosing colorectal cancer."
In an interview with "The Gray Sheet," Douglas Rex, M.D., a colonoscopy expert at Indiana University Hospital in Indianapolis and consultant to Given, explained that researchers are optimistic that PillCam COLON 2 will be able to detect more polyps in the colon than the first-generation version.
The new device's camera will take pictures at a faster frame-rate and with a wider angle of view, allowing it to image more of the colon.
The PillCam COLON 2 will be accompanied by a new colon preparation treatment. Rex explained that the current preparation treatment causes the colon to release mucus which clouds the clear polyethylene glycol and water solution, so he hopes the new solution will disperse or suppress the colon's creation of mucus.
- Reed Miller
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