Anti-obesity test device tries to fool tummy

NOTE: A clinical trial is a human experiment in which the results are unknown. This is not free treatment or a free procedure that has been approved by the FDA. The risks are unknown and could be serious, even life threatening. Anti-obesity test device tries to fool tummy into thinking it's already full A handful of Portland-area patients will receive a Dutch company's experimental "Tantalus" in operations at Legacy Good Samaritan Thursday, October 21, 2004 BOAZ HERZOG Portland will be one of three sites nationwide where doctors will soon test technology designed to help the growing number of obese undergo weight-loss surgery without radical changes to their digestive systems. Legacy Good Samaritan Hospital & Medical Center plans to begin implanting a pacemaker-like device resembling a small metal can in six to eight test patients as early as December. The device, placed under the skin at the front of the abdomen just below the rib cage, will fire electronic pulses through tiny wires leading to the stomach wall. The desired result: The body is tricked into feeling full after eating a small amount of food, followed by gradual weight loss. The Dutch company behind the implant, called the Tantalus, is in a race with researchers worldwide to develop better treatments for obesity. Doctors at Oregon Health & Science University, for example, helped to develop a nasal spray now in early clinical trials that delivers a hormone into the bloodstream which triggers a feeling of fullness. The market potential of such treatments has left medical device and drug companies salivating. Obesity is blamed for contributing to rising health care costs. Studies point to increased rates of hospitalization and medication usage by obese patients. Obese patients fed up with diets that don't produce lasting results are increasingly turning to weight-loss surgery for help. The most common forms of the surgery rearrange the body's anatomy, either by stapling parts of the stomach or changing the pathway for digestion. The Tantalus "leaves the stomach as is," said Dr. Emma Patterson, the director of Legacy's Obesity Institute who will implant the Tantalus in Portland-area patients. "That's the appealing part of it." Research into the Tantalus is in its infancy. MetaCure, based in the Netherlands, is sponsoring a five-month study of the device in 16 U.S. patients in Portland, Los Angeles and Cleveland to test its safety. Earlier this year, the company launched its first such test on a dozen patients in Europe. If tests prove successful, MetaCure plans to ask the U.S. Food and Drug Administration for approval to conduct a longer-term study to test how well the Tantalus can aid in weight loss. Early results from test patients in Austria show a loss of 14 percent to 30 percent of their excess body weight after three months, Patterson said. A Tantalus patient manual cautions that surgically implanting the device may cause infection, perforations of the stomach or bowel, or other complications. It also notes a small risk of death. Tantalus tests have shown complication-free results so far, said Walid Haddad, the manager overseeing MetaCure's obesity project. "We are very confident," he said, adding that MetaCure expects to begin selling the Tantalus in Europe sometime next year. Cracking the U.S. market will probably take at least two years, Haddad said. No price has yet been set for the Tantalus, but Patterson expects it to come close to the $25,000 average cost at Legacy for weight-loss surgery. Patients involved in the Tantalus tests will be paid as much as $1,175 for their participation. MetaCure is picking up all costs associated with the tests, including any care not covered by a participant's insurance for any illnesses or injuries resulting from the study. Tantalus is named after a wicked king in Greek mythology condemned to stand in water that receded when he tried to drink and beneath fruit too high to reach. To apply to participate in the Tantalus study, call 503-413-2153.