When Jamie Finley begins an experimental weight management treatment later this month, she could receive a shock. Actually, the 41-year-old Woodbridge mother and business manager could get a whole series of them, and that's fine with her.
The shocks will come from a machine the size of a half dollar she's volunteered to have surgically implanted in her stomach as part of a clinical trial at the George Washington University Hospital Weight Management Program. Finley, a former Arkansan who grew up on Southern fried chicken and eggs cooked in bacon grease, hopes the novel device -- called an implantable gastric stimulation system -- will help her control her appetite and shed some of her roughly 200 pounds. And keep them off.
Tired of trying to shed excess weight, Jamie Finley will begin a trial of the gastric pacemaker.
(Robert A. Reeder - The Washington Post)
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She's tried other means to reach that goal, improving her diet and trying reputable weight loss programs, but the extra pounds have always come back.
"This is a battle I've fought many times over," she said.
That makes her just the kind of patient researchers are seeking to try an approach less radical -- and therefore, with potentially broader application -- than gastric bypass.
Made by Transneuronix Inc. of Mount Arlington, N.J., the device consists of a battery-powered pulse generator and a 15-inch lead wire with two electrodes. At first glance, it resembles a stopwatch with a tail.
Like a heart pacemaker, the device sends out impulses that are generally undetectable to the patient, according to bariatric surgeon Scott Shikora of the Tufts-New England Medical Center in Boston, who has been testing the devices on obese patients for five years.
In this latest round of clinical trials, researchers will study whether the device fosters weight loss by causing an uncomfortable feeling of fullness -- satiety -- soon after a person begins eating.
In an earlier study of 30 obese patients receiving the pacemaker, 80 percent lost at least some weight in the first nine months after surgery, and 60 percent lost more than 10 percent of their body weight. Some patients lost more than 100 pounds, according to Shikora. But questions remain about how the pacemaker compares with other appetite-control methods in effectiveness and safety.
Over the next few months, GW researchers plan to begin testing the device on 30 more patients. Similar trials will take place at seven other medical facilities, including Tufts and the University of Pennsylvania.
About 500 patients worldwide have had the device implanted since the mid-1990s, including 150 in the United States, according to Transneuronix Executive Vice President Steve Adler. He's optimistic this latest series of clinical trials will lead to Food and Drug Administration approval of the device. The implant procedure has been available in Europe for about a year.
Bypassing a Bypass
In an operation that takes about an hour, the pulsor is slipped through a two-inch incision in the belly into a shallow pocket in the abdominal wall. The lead and electrodes are then attached to the stomach muscles with permanent stitches.
As with any surgical procedure, there are risks. Some of the gravest include perforation of the stomach, pulmonary embolism and complications linked to use of anesthesia. But Shikora, who's worked with the pacemakers more than any other U.S. doctor, said he has yet to witness any problems.
"It's been remarkably complication-free," he said.