02 Nov 2006
When swallowed by a patient, a tiny video camera "pill" will deliver direct diagnoses of various digestive tract conditions.
Given Imaging of Israel has published the findings of the first clinical trials of its PillCam Colon, a tiny video capsule designed for the diagnostic visualization of the colon. Promising results reported by three separate studies indicate that the device could offer a favourable alternative to traditional colonoscopy.
The PillCam Colon diagnostic process is relatively straightforward: the patient swallows the capsule with water and images are acquired as the device passes through the digestive system. The 11×31 mm capsule contains automatic lighting control, as well as tiny cameras at each end that capture four images per second for up to 10 hours.
The images are transmitted from the capsule via an array of sensors on the patient's body to a data recorder worn round their waist. On completion of the procedure, the data are processed on the Given workstation, with the company's Rapid software being used to review the video and generate a clinical report.
In a further boost to PillCam Colon's commercial potential, it has just been awarded the CE mark, which allows it to be marketed throughout the EU. Given Imaging plans to file for marketing clearance of the capsule with the US Food and Drug Administration by the end of 2006.
Data to date
A clinical trial conducted at three Israeli centres - Rambam Medical Center, Hillel-Yaffe Medical Center and Bikur Holim Hospital - compared PillCam Colon with colonoscopy for colorectal tumour diagnosis (Endoscopy 2006 38 963).
The combined results from both screening methods identified polyps in 45 out of 84 patients, with PillCam Colon finding 76% and colonoscopy 80%. Of the 24% of patients with significant findings (at least one polyp measuring 6 mm or three or more polyps of any size), PillCam Colon identified 70% and colonoscopy 80%.
"The ideal method to visualize the colon should be non-invasive, convenient, safe, well accepted by the target population, show high diagnostic accuracy and be cost-effective," said Rami Eliakim, chief of gastroenterology at Rambam Medical Center and lead investigator of the multicentre study. "If further study results confirm the recent data, PillCam COLON could represent a patient-friendly method for physicians to visualize the colon."
A similar investigation was conducted at Erasme University Hospital in Belgium (Endoscopy 2006 38 971). In a study of 36 patients, PillCam COLON identified 19 of the 25 patients with positive findings and 10 of the 13 with significant polyps detected by colonoscopy. In addition, the video capsule identified seven polyps not captured during colonoscopy. The overall sensitivity of PillCam COLON in detecting polyps was 77% and specificity was 70%.
Jacques Devière, professor of medicine at Erasme University Hospital and president-elect of the European Society of Gastrointestinal Endoscopy, commented: "While still early, these data provide compelling evidence that PillCam COLON could be used as one of the diagnostic tests used by doctors to visualize abnormalities of the colon."
A multicentre study in the US has taken things a step further - performing a blinded trial comparing the effectiveness of PillCam Colon with both standard colonoscopy and virtual colonoscopy.
Investigators at Mount Sinai Medical Center (New York, NY), Indiana University Hospital (Indianapolis, IN), and Oregon Health and Science University (Portland, OR) evaluated 25 patients over the age of 50 who had not had a colonoscopy within the past five years or a family history of colon cancer.
Of the 25, 44% had significant findings confirmed by standard colonoscopy (blinded or unblinded). PillCam Colon identified 64% of the significant polyps, virtual colonoscopy identified 55% and blinded standard colonoscopy 82%. The investigators concluded that the video capsule is a promising new technology for visualizing polyps in the colon.
Given Imaging plans to release the PillCam Colon onto the market gradually, following the completion of additional clinical trials. "Our ultimate goal is to deliver innovative, patient-friendly products that improve how gastrointestinal disorders are diagnosed and treated," said president and CEO Homi Shamir. "To this end, the initial PillCam Colon data are encouraging and we believe it will be an effective tool for physicians to visualize the colon."