Israeli scientists invent a capsule that travels through the body and produces full-color images, enabling painless gastrointestinal diagnoses.
By Judy Siegel-Itzkovich
The unique M2A capsule developed by Given Imaging Ltd. of Yokneam - contains a miniature video camera, flashing light, battery and computer chip. Miniature electronics and complementary technology allow the capsule to transmit high-quality video images, allowing doctors to view a range of disorders of the small intestine.
After fasting for eight hours, the patient swallows the 2.5-centimeter-long capsule with a glassful of water, and then buckles on a belt bearing a wireless recorder. The recorder receives signals as the capsule (which is not affected by the highly acidic environment of the gastrointestinal system) is propelled through the small intestine by peristalsis - the natural contracting motions of the digestive system. The patient may conduct his normal daily activities - eating, working, playing, and sleeping - until the capsule is discharged from the body along with the stool. It is then retrieved and taken to a special computer workstation, where the images are processed using Given Imaging's RAPID (Reporting and Processing of Images and Data) software. The end product is a short video clip of the small intestine together with additional relevant information from the digestive tract. .
The process enables gastroenterologists to find sources of unexplained bleeding, abnormal growths, as well as signs of irritable bowel syndrome and other conditions, which may then be treated as necessary. Although it is not expected to replace endoscopies or colonoscopies - which can be utilized for treatment (e.g., taking biopsies and pinching off pre-cancerous polyps) as well as for diagnosis - the developers believe that the new technology will save the health system considerable money, as less-accurate and painful endoscopies are much more costly than the $300 capsule. Company officials explain that it is an adjunctive tool which they believe will eventually play a significant part in gastroenterological medicine.
In order to get approval from the US Food and Drug Administration, the device will be tested on 20 patients in London, New York and Israel. It is not yet planned to be used on patients who have had major abdominal operations, a history of abdominal obstruction, those with pacemakers or diabetes, or on pregnant women.
"The main potential advantage for patients is that we believe the device will prove to be completely painless - they've just got to swallow a capsule," Prof. Paul Swain of the Royal London Hospital explains. "We may be able to image the lower part of the small bowel while the patient is walking around. The study is designed to evaluate these aspects of the device."
The clinical trials will determine whether the wireless capsule technology can detect pathologies that are notoriously difficult to diagnose. Prof. Eitan Scapa, who heads the gastroenterology department at Assaf Harofe Hospital in Tzrifin - near Tel Aviv, notes that many patients suffer blood loss from their small intestine, the source of which cannot be determined. "They often have to get regular blood transfusions and take iron supplements. Now we can locate the cause, and the problem can be fixed in surgery."
Given Imaging vice president Pablo Halpern says that if the trials are successful, the device could be available for diagnosing patients in the US and Western Europe by 2001. The company may then license the technology to others who want to adapt it and use it for producing video images of the cancer-prone large intestine - colon, the gynecological tract, and perhaps even the cardiovascular system.
"The system is intended to let us see new parts of the human body that we really haven't examined before," adds Dr. Blair Lewis, who will be carrying out the trials at the Mount Sinai School of Medicine in New York. "There are lots of patients, both young and old, for whom this method of diagnosis could be extremely worthwhile."