The modality you swallow: Capsule-sized camera embarks on real 'Fantastic Voyage'

A camera no larger than a nighttime cold capsule could soon be traveling through patients' intestines, pinpointing disorders of the digestive tract and transmitting real-time images to physicians.

Inventors of the capsule-camera believe it will someday replace endoscopies, colonoscopies, and other uncomfortable or painful diagnostic exams in which a flexible fiber-optic tube is inserted in the rectum or down the throat. According to Medical Industry Today, approximately 8.2 million gastrological endoscopies are performed each year in the U.S., and the number is growing at a rate of 9% a year.

The patented capsule-camera, called M2A, is actually a disposable video color-imaging capsule. The patient swallows it after being outfitted with special Walkman-like recording devices that receive signals transmitted by the capsule through an array of sensors placed on the body. The recording devices, which are worn on a belt, are subsequently removed and the images and data downloaded onto a computer workstation equipped with proprietary software. The ambulatory belt permits users to go about their daily activities during the "GI examination." The capsule is later excreted normally.

Given Imaging, an Israeli company with North American headquarters in Atlanta, holds the patent on the device. It is being evaluated in patients with suspected small bowel disorders at Mount Sinai School of Medicine in New York City. Results of the trial will be submitted to the FDA as part of Given's regulatory application to market the system in the U.S. Similar clinical trials are taking place in London and Israel.

"The Given system is intended to let us see a new part of the human body that we really haven't examined before," said Dr. Blair Lewis, an associate clinical professor of medicine at Mount Sinai. "There are lots of patients, both young and old, for a variety of diagnoses where this type of endoscopy could be extremely worthwhile."

Proponents say the main advantage for patients is that the device will be completely painless; patients need only swallow a capsule.

The capsule also has the potential to reach parts of the gut that are not accessible with conventional endoscopes. This would give physicians to ability to image the lower part of the small bowel completely painlessly. Patients need no sedation and can walk around normally while having the test done.