An Israeli company is ready to start testing its "video pill," a tiny video camera that monitors the human intestines of patients.
The M2A Swallowable Imaging Capsule transmits two images a second. Designers for Given Imaging used their training in Israel's military industries to design the sensor, transmitter, and two chips that are the basis of the device.
The video-quality images are picked up by a Walkman-sized receiver that is worn on a belt around the waist. The images are then loaded onto a hard disk and examined by a doctor.
The capsule, which contains a miniature video camera, a battery, a tiny light, and a transmitter, passed preliminary U.S. Food and Drug Administration tests that were given to animals and healthy volunteers. Given Imaging executives in Jerusalem said they will launch clinical testing next month.
FDA spokeswoman Sharon Snyder said that she could not confirm or deny the status of FDA action due to trade regulations. She noted, however, that the average elapsed time for FDA approval of diagnostic devices in 1999 was just over 12 months. Given Imaging applied for FDA approval in May.
Company researchers claim the pill, 1 inch in length and one-third of an inch in diameter, offers a better and less painful alternative to conventional endoscopy, in which a probe is inserted orally or rectally.
"The patient swallows it, and can go out, doing their own business," said Eitan Scapa, a gastroenterology specialist at Tel Aviv's Assaf Harofe hospital.
Other researchers have expressed skepticism that the images would match fiber-optic endoscopes for detail, and they raised concerns that the camera's view might be obscured by bubbly saliva or green bile.
The capsule cannot be stopped or steered to collect close-up details of the small intestine's millions of interior wrinkles where ailments often occur. Nor is it fitted with surgical tools like a conventional endoscope to take biopsies, treat bleeding lesions, and remove polyps.
The pill, excreted after about four hours, was designed to examine the small intestine especially, Scapa said. Current probing methods can only reach the upper third of the intestine.
An independent gastroenterologist, however, said the capsule poses medical risks.
"It is a revolution, no question about it," said Simon Bar-Meir, director of the gastrointestinal department of the Chaim Sheba Medical Center in Tel Hashomer. "But the main problem is that if there is a partial obstruction in the small intestine, there is a risk that the pill will get stuck there."
He said such a situation could become life-threatening.
"A patient who might have come in for diagnostical reasons may end up in the emergency room for intestinal obstruction," Bar-Meir said.
Given Imaging officials said such complications were unlikely but acknowledged that for now, it would prohibit use to those who have had major abdominal operations, a history of abdominal obstruction, pregnant women, those with pacemakers, and diabetes patients.
Company officials say the pill itself will cost about $300 for patients. The entire system will cost $30,000 for hospitals, including the receptors and computer station.
