"The results of this study show that wireless capsule endoscopy is able to diagnose Crohn's disease more accurately than traditional methods leading to better and earlier care of patients suffering from this debilitating disorder", stated Dr. Zvi Fireman, Head of the Gastro-enterology Department of Hillel Yaffe Medical Center, Hadera, Israel, who conducted the study. "Now that we have made a diagnosis for these patients who have been suffering with the symptoms of Crohn's disease for over six years, we can start managing their treatment."
The study evaluated seventeen patients with suspected Crohn's disease whose small bowel x-rays and upper and lower gastro-intestinal endoscopic findings were normal. Of the seventeen study participants, twelve were diagnosed with having Crohn's Disease of the small bowel resulting in a diagnostic yield of 71 percent. In addition, the results showed a normal appearing small bowel in the remaining five patients, ruling out the occurrence of Crohn's Disease. In conclusion, the trial demonstrated wireless capsule endoscopy as being an effective tool for diagnosing patients with suspected Crohn's Disease undetected by conventional methods.
Given Imaging develops, produces, and markets the Given Diagnostic System featuring the M2A Capsule Endoscope, the only non-invasive method for direct visualisation of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule which is ingested by the patient. The M2A capsule passes naturally through the digestive tract, transmitting high quality colour images, without interfering with the patient's normal activities.
The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. Distribution channels for the system have been established in more than 50 countries worldwide. The M2A has been utilised to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease, and other malabsorption disorders, benign and malignant tumours of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of paediatric small bowel disorders. More information on the Given Imaging Capsule technology is available in the VMW September 2001 article Given Imaging's Capsule Imaging Technology market-cleared in the European Union, USA, Australia, and Israel.