A stomach-pumping device to treat obesity that was developed and tested by Washington University researchers is now available to patients.
The AspireAssist device is a reverse feeding tube that sucks food out of the stomach after each meal through a port implanted in the abdomen. The device can remove up to 30 percent of calories from a meal before it is digested. It was approved today by the U.S. Food and Drug Administration.
A developer of the device, Dr. Samuel Klein, is director of the Center for Human Nutrition at Washington University. In the initial local study, seven out of 10 participants who used the device for two years experienced an average of 20 percent weight loss.
“It’s a form of calorie restriction that takes into account the desire to eat,” said Dr. Shelby Sullivan, who led the pilot study of 11 patients in St. Louis with funding from the Pennsylvania company Aspire Bariatrics.
Candidates for the device should have a body mass index of 35 to 55. For a woman who is 5 feet 4 inches, that’s about 205 to 320 pounds. In a 5 foot 10 inch tall man, it translates to 245 to 385 pounds. The average patient in the clinical trials went from a body mass index of 50 to 35 after the therapy, researchers said.
Eric Wilcoxon, 44, received the device in a clinical trial at Washington University in October 2013. At 6 feet 3 inches, he’s gone from 389 pounds to 270 today and still uses the device three times daily.
Wilcoxon, of Poplar Bluff, said he has lost and regained 125 pounds twice on different diets. Now he coaches his son’s football team and stays active hunting, fishing and swimming. His knee replacement surgery for December was canceled because his pain has improved. Wilcoxon said he plans to keep the aspiration device indefinitely.
“It gives me the willpower that I obviously did not have or I would not have been 400 pounds,” he said. “It works. You’ve got to think about chewing your food, you’ve got to think about what you’re going to eat.”
Critics have called aspiration therapy “medical bulimia” because of similarities to the eating disorder marked by bingeing and purging food.
To that, Wilcoxon said “there is no splurging and purging” and the device simply exaggerates the effects of modifying your diet.
” If somebody wants to criticize how this process works, they need to take about ten steps in my shoes at 400 pounds and feel how miserable I was,” he said. “It was going to kill me.”
Sullivan said the patients did not exhibit any bingeing or other abnormal eating behaviors, and in fact ate fewer calories because it takes longer to chew food into the desired consistency to aspirate it out of the stomach.
“Patients eat less. You have to chew food until it disintegrates. They have to chew so much they just get sick of chewing,” she said.
A tube is inserted in the stomach in a 15-minute outpatient procedure, leaving a valve outside the skin. The user attaches an exterior tube 20 to 30 minutes after eating and the food is removed via gravity and emptied into the toilet within 10 minutes.
The biggest misconception of the device is that it enables people to eat a lot of food without consequence. But seeing the food after they’ve swallowed it helps change patients’ eating behaviors, Sullivan said. And it is easier and quicker to chew fruits and vegetables thoroughly.
“If you eat a large meal you can’t aspirate it,” Sullivan said. Plus, “the tube is clear, you see what’s coming out and healthy food looks better.”
In a larger clinical trial reviewed by the FDA, patients using the device along with nutrition and exercise counseling lost an average 12 percent of their weight compared to 4 percent for a control group who only received counseling.
Side effects included initial nausea, vomiting, diarrhea and constipation. Risks of placing the device include bleeding, pain and infection at the valve site.
The cost of the device has not been released, although it could be comparable to another obesity device, a stomach balloon priced around $6,200. It is too early to know if insurance will cover the aspiration device.
Sullivan said one benefit to the device is it can be used in patients with a higher body mass index who may not be candidates for gastric bypass surgery. The aspiration device also does not alter the patient’s anatomy or require any severe food restrictions like the surgery does.
“I like it because it gives patients a tool that is a long-term weight management strategy that changes their mindset about food,” Sullivan said. “If your goal is to get people healthy by having them eat less and develop better eating behaviors, this does that.”