01: New, FDA-Approved Weight Loss Device
The AspireAssist is a new, FDA-approved weight loss solution for people with obesity. Unlike many other weight loss procedures, it’s non-surgical and reversible.
In a U.S. Clinical Trial, patients lost 3 times more weight on than those who received only diet and exercise counseling¹. The most successful patients lost over 100 pounds in the first year.
Placing the device is an outpatient procedure. Patients can often return home within one to two hours, and be back at work quickly.
The quick 15 minute procedure is performed under “twilight anesthesia” – general anesthesia is usually not required.
Healthy, Normal Lifestyle
Although there are no specific foods that are off-limits with the AspireAssist, you’ll gradually learn healthier behaviors with the lifestyle counseling program, to help keep the weight off long-term.
The AspireAssist can be removed at any time through a 10-minute outpatient procedure. It is usually performed under twilight anesthesia.
Because the procedure and device are relatively simple, the AspireAssist may be affordable for patients who cannot afford bariatric surgery.
02: How it Works
The AspireAssist works by reducing the calories absorbed by the body, while helping you make gradual, healthy changes to your lifestyle. After eating, food travels to the stomach immediately, where it is temporarily stored and the digestion process begins. Over the first hour after a meal, the stomach begins breaking down the food, and then passes the food on to the intestines, where calories are absorbed. The AspireAssist allows patients to remove about 30% of the food from the stomach before the calories are absorbed into the body, causing weight loss. You’ll also need to chew carefully and eat mindfully, which helps give time for the fullness signals from your stomach to reach your brain.
To begin therapy, a thin tube will be placed in your stomach that connects the inside of your stomach directly to a discreet button on the outside of your abdomen. After each meal, the device enables you to empty, or “aspirate”, up to 30% of your meal into the toilet through this tube by connecting a small, handheld device to the button. The device is about the size of a smartphone, and stores away in a small case afterwards.
The aspiration process is performed about 20 to 30 minutes after the entire meal is consumed and takes 5 to 10 minutes to complete. The process is performed in the privacy of the restroom, and the food is drained directly into the toilet. Because aspiration only removes a third of the food, the body still receives the calories it needs to function.
This therapy is used in conjunction with lifestyle counseling. This program combines one-on-one counseling and group support meetings to encourage healthier food choices, smaller portion sizes, and increased physical activity. The therapy also requires careful and comprehensive monitoring by a physician to ensure you are losing weight in a healthy manner.
03: Simple Procedure
The AspireAssist tube is placed during a 15-minute outpatient procedure. Patients can usually return home within one to two hours, and many return to work very quickly compared to invasive bariatric surgeries. The does not usually require general anesthesia, and instead is typically performed under “twilight anesthesia” (also called conscious sedation or Monitored Anesthesia Care), which is used during many dental procedures. The procedure is very similar to the routine placement of feeding tubes. For the past 35 years, feeding tubes have been used for people who cannot eat through their mouths.
04: Clinical Results
The AspireAssist has been studied in hundreds of patients in both the US and in Europe. In a large U.S. clinical trial with 171 participants, people using the AspireAssist lost 3 times as much weight as people who received only lifestyle counseling. The most successful patients – those who aspirate regularly and learn to make healthier choices – have lost 100% of their excess weight with the AspireAssist and have maintained that weight loss for more than four years so far. Compared to other approaches, the AspireAssist has similar results without requiring invasive alterations to the anatomy or digestive process.
05: Medical Monitoring
When you choose the AspireAssist, you are not alone in your weight loss journey! Your medical team will monitor your progress carefully to make your therapy as successful and safe as possible. They will work with you to come up with a schedule to closely watch the following:
Aspirating regularly and learning to chew well are the most important parts of making this therapy work for you to reach your weight loss goals. Your medical team will help you learn how to fit the AspireAssist into your daily life – so it becomes a part of your routine, just like brushing your teeth.
Because aspiration removes only 30% of your meal, it is unlikely to cause nutrient deficits when used properly. Much like reducing portion sizes through a traditional diet, your body will still receive the vital nutrients it needs if you eat well-balanced meals. Lifestyle counseling, which is provided in conjunction with the AspireAssist, will help you improve your food choices. As with many weight loss methods, your physician may recommend that you take a multivitamin with the therapy to keep you healthy as you reduce your caloric intake.
FLUIDS AND ELECTROLYTES
Your electrolyte levels will be monitored regularly while you are using the AspireAssist, to make sure they stay in a normal range. In our clinical trials, there has been no evidence of serious electrolyte imbalances or dehydration as a result of the AspireAssist. In fact, many people find they are drinking more fluids with Aspiration Therapy, as drinking fluids with meals makes aspiration easier.
BUTTON SITE HEALTH
Much like with traditional feeding tubes, the button site on the abdomen should be kept clean and dry. Your medical team will help you learn to care for the site, and will check it regularly to ensure that it remains healthy. With the exception of a few activities such as deep-water diving, the AspireAssist will not limit normal physical activities, such as swimming or jogging.
06: Lifestyle Counseling
Patients who make healthy diet and exercise changes will get the most benefit from the AspireAssist. Over time, with healthier food choices and increased physical activity, you may be able to reduce the number of times you aspirate to once a day or less, or have the device removed completely. To help you make these changes, lifestyle counseling is provided with the AspireAssist. Lifestyle counseling may be provided in individualized one-on-one sessions, and/or group sessions with other patients.
Lifestyle counseling will help you address some of the causes of overeating, including emotional and situational triggers. Often, overeating is caused by environmental factors such as stress or special events, rather than hunger. As you begin to identity your triggers, you may be able to avoid them so that you don’t snack or overeat as frequently. You will also learn about appropriate portion sizes for your body and activity level, how to make healthier food choices, and how to incorporate the AspireAssist into your dietary routine.
The program also encourages compliance with aspirating after each meal by offering tips to incorporate aspirating into one’s daily routines. Lastly, this program helps patients stay motivated to maintain their weight loss long-term. Many patients find that the AspireAssist makes healthy lifestyle changes easier to make and maintain, because they can see results of their efforts faster.
07: Safety Information
The AspireAssist has a low risk of serious complications, similar to feeding tubes which have been used for over 30 years. Although the it does not have many of the risks associated with invasive surgical procedures, there are risks with any procedure. In clinical studies, the most common side effects were abdominal discomfort after the procedure, and skin irritation around the button site. Other less likely risks include infection and ulceration, which can generally be resolved with medication, tube removal, or tube replacement. Discuss the potential risks and benefits with your doctor to help determine if the AspireAssist is right for you.
The tube can be removed at any time through a simple 10-minute outpatient procedure. Removal is similar to the placement procedure, and is performed with twilight anesthesia (general anesthesia is not typically required). The tube site usually closes naturally on its own afterwards.