In addition to expanding our knowledge by research into patient outcomes, the Institute is also involved in a number of clinical trials. Before any drug, device or surgery makes it to market it goes through a series of stringent clinical trials.
A clinical trial is a research study conducted with patients who have been diagnosed with major illness and generally involves testing of new treatments (whether drugs or devices) or finding ways of improving existing treatments. Clinical trials are conducted all over the world in most large hospitals in an attempt to improve treatment for many diseases. The main objective of a clinical trial is to compare two or more groups of subjects, using two or more treatment options to determine the effectiveness of a proposed drug or biological treatment.
Clinical trials are carefully and ethically designed to allow truthful and precise collection and analysis of information to find out more about a disease. Such trials help discover whether a promising new treatment is safe and effective, as well as giving a better understanding of the current standard treatment, in the hope of improving the side effects experienced by many patients.
Implantable Vagal Block Therapy (VBLOC) Under Clinical Investigation as a Treatment for Obesity.
EnteroMedics Inc. is developing implantable systems to treat obesity and other gastrointestinal disorders. Its VBLOC™ Therapy is designed to precisely control, or "neuroregulate", nerve and organ function. The vagal nerves regulate much of the activity of the stomach and the pancreas and are also believed to play a significant role in the signaling of satiety and hunger.
VBLOC Therapy delivers high frequency, low energy electrical signals through laparoscopically implanted leads to block vagal nerve transmission. The delivery of energy to the nerves is intermittent and the effects of VBLOC Therapy on the nerves and end organs are intended to be reversible. The system is designed to be precisely programmed and non-invasively adjusted to meet individual needs. Unlike the majority of existing surgical obesity treatments, normal digestive system anatomy is preserved. Clinical trials are intended to show that VBLOC Therapy will help those who are morbidly obese manage their weight.
Currently available surgical obesity treatments such as gastric bypass surgery and laparoscopic banding alter normal anatomy to reduce stomach size. Clinical studies will demonstrate if VBLOC Therapy offers a safe and effective alternative to the well known complications associated with existing approaches to bariatric surgery.
VBLOC Therapy is undergoing clinical investigation for obesity treatment at select centers within and outside the United States. The Australian Institute of Weight Control’s clinics in Adelaide and Sydney have been selected as the only clinical trial sites outside the U.S.A.
If you are willing to make a commitment to losing weight and participating in a medical weight management program that will provide education and advice on diet, exercise and behavioral modification—and you meet the eligibility requirements of the clinical investigation—VBLOC™ Therapy might be for you.
