NDDIC News

Eye on the Intestine: New Capsule Endoscope Awaits FDA Approval for U.S. Testing

Examining the stomach and intestines may become much easier for gastroenterologists. A new wireless endoscope that takes images of the digestive tract was developed and recently tested by researchers from England and Israel. The device, in the form of a small capsule that the patient swallows, is awaiting approval by the U.S. Food and Drug Administration (FDA) for testing.

Test participants will have been referred for endoscopic exams of the small intestine, including exams to check for sources of bleeding. Some participants will receive the capsule and the rest will undergo conventional endoscopy, and researchers will compare the findings.

Unlike conventional endoscopes, says Paul Swain, M.D., a researcher from England, the capsule has no external wires or cables and the intestines do not have to be inflated with air. The capsule contains a miniature video camera, a battery, a tiny light, and a transmitter. The patient simply swallows the capsule and proceeds with his or her daily activities. According to Dr. Swain, the capsule "is propelled by peristalsis through the gastrointestinal tract and does not require a pushing force to propel it through the bowel." The capsule can record images for more than 5 hours.

Ten volunteers participated in the first study in England. None had trouble swallowing the capsule or discomfort as it traveled through their digestive tracts. The capsules sent images of the stomach, intestines, and colon to portable recorders that the volunteers wore on belts.

Dr. Swain said that the images from the capsule "are not yet quite as good as the best video-endoscopic images from conventional endoscopes." He added, however, that the capsule images obtained from the small intestine "are already superior to those obtained with the sonde-type long fiberoptic instruments."

Dr. Swain said that the capsule appears to give researchers complete views of more than 80 percent of the gastrointestinal tract, and he expects improvements as more studies are conducted. He added that the cost is competitive with conventional endoscopes and should be reasonably inexpensive if manufactured in large numbers.

Despite the success of the first studies, Dr. Swain found it unlikely that the capsule will replace endoscopy or colonoscopy altogether. "The capsule does not take biopsies," he said, "and it is hard to imagine that it could remove large polyps from the colon."

Upon FDA approval, Blair Lewis, M.D., of Mount Sinai Hospital in New York, will direct tests of the capsule in the United States.

NIH Publication No. 01–4552
March 2001