The device consists of a tube that is endoscopically placed via an incision in the skin into the stomach and a disk-shaped port valve that is positioned outside the body, flush with the abdominal skin. About 20 to 30 minutes after eating, the patient attaches the external connector of the device and tubing to the port gate, opens the valve and drains the contents into the toilet. This process takes about 5 to 10 minutes.
Deputy director for science and chief scientist in the Food and Drug Administration's Centre for Devices & Radiological Health, William Maisel, MD said in an FDA news release that the AspireAssist approach assists provide effective control of calorie absorption, which is a key concept of weight-management treatment; and that patients require to be observed by the healthcare provider and should follow a lifestyle program to assist them develop healthier eating habits and decrease their calorie intake.
The device is planned for use in obese patients aged 22 years or older with a body mass ratio of 35 to 55 who have made effort and failed to lose weight via nonsurgical weight-loss therapy. It should not be utilized for temporary durations in moderately overweight individuals or in patients with eating conditions.
The decision follows an assessment of data from a clinical trial of 111 patients treated with the device and lifestyle temperance and 60 control patients who got lifestyle therapy only. After 1 year, those who utilized the device lost an average of 12% of their body weight, in comparison with 3.6% for those in control group. Patients in both groups had small developments in obesity related conditions such as hypertension, diabetes and quality of life. The FDA elucidated in the news release that these progress may be attributable to the lifestyle treatment, which includes nutrition and exercise guidance.
Patients must be observed closely; the device certainly stops working after 115 revolutions, or about 5 to 6 weeks of therapy, to make sure that the patient returns for medical result and a stand-in part for the device. The tube must be reduced as the patient's abdominal circumference gets smaller so that the disk stays flush with the skin. Patients also need constant advice and encouragement on lifestyle modification.
Adverse effects include vomiting, diarrhea, constipation ,occasional indigestion and nausea.
Associated Risks
There are risks associated with endoscopic surgical placement of the gastric tube. They are as follows; sedation related to breathing problems, indigestion, vomiting, infection, pain, nausea, sore throat, abdominal bloating, pneumonia, bleeding, inflammation of the abdominal lining, unintended puncture of the stomach or intestinal wall, sore in the stomach and death.
A number of risks related to the abdominal opening for the port valve may involve removal of the device. These include leakage, irritation, abdominal pain, discomfort, hardening or inflammation of the skin around the site of the tube placement, migration of the device into the stomach wall and bleeding and/or infection around the site where the tube is placed. Persistent fistula (an abnormal passageway within the abdominal wall and the stomach) may take place after the device is removed.
Contraindications
There are some conditions that suggest that the device should not be used. They are as follows; night eating syndrome, pregnancy or lactation, uncontrolled hypertension, inflammatory bowel disease, diagnosed bulimia or binge eating disorder, stomach ulcers or certain types of previous abdominal surgery. The device is also should not be used in those with a history of chronic abdominal pain, severe pulmonary or cardiovascular disease, patients with a high risk for medical complications from an endoscopic procedure or coagulation disorders.