Notes

Orbera Clinical Study
ORBERA is a weight loss device that can limit the amount of food a person can eat by using a balloon inserted into the stomach. The balloon has a soft, smooth surface and is filled with sterile saline solution. It can hold between 400 and 700 ccs of fluid, which is sufficient to reduce a person's intake of food.
Obalon Balloon System

The Obalon balloon system is a non-invasive procedure that uses a small balloon to treat gastric reflux. This treatment requires a single appointment and usually takes about ten minutes. Patients are awake and conscious during the procedure. Post-obtalon patients are encouraged to follow a diet and exercise regimen for at least a month. In most cases, the balloon remains in the stomach for about six months.

The Obalon Balloon System is intended for overweight adults who are 30 to 40 kilograms (40 pounds) over weight. The procedure is performed in a fluoroscopy suite at the doctor's office. The balloon is then placed in the stomach, where it takes up space and makes patients feel full faster. After six months, the balloons are removed and patients can resume normal activity. Patients usually lose between 20 and 40 pounds using the Obalon Balloon System.

The Obalon Balloon System is an FDA-approved, swallowable device that takes up stomach space. It is intended to aid patients in losing weight by helping them feel full more quickly. It is usually used with a diet and exercise plan and is intended for patients with a BMI of 30 to 40.
Efficacy

The clinical study for Orbera involves obese adults with a BMI over 30 kg/m2. The goal of this study is to evaluate the safety and efficacy of Orbera. The study is designed to enroll approximately 255 patients at up to 20 sites in the U.S. The clinical trial will involve both male and female participants. The trial is expected to conclude in 2020. While the efficacy of this medication is still in question, the system does seem to have some advantages, particularly regarding patient satisfaction.

For patients who cannot undergo surgical procedures, ORBERA offers a safe and effective solution. The procedure involves an incisionless balloon that is placed in the stomach. The balloon is filled with saline. The patients are then given a diet and medication for up to six months.

The Orbera balloon has a low rate of serious adverse events. The device causes low levels of gastric ulcers, GERD, and balloon migration. Other complications include small bowel obstruction and perforation. Although rare, spontaneous intragastric balloon deflation is also possible.
Safety

Orbera is a liquid-filled indwelling gastric balloon (IGB) that can be used to help with weight loss . It is one of the most widely used IGBs in the world. It has been on the market for over 20 years and has been approved in many countries. This long history of successful use has helped the medical community to gather reliable evidence for the device's safety and efficacy. One such study, conducted in Brazil, pooled the experience of more than 40,000 procedures. In addition, several meta-analyses have demonstrated the safety and efficacy of Orbera compared to diet alone or placebo.

Although Orbera has been approved by the FDA, doctors have reported several complications related to the device. One of these complications is hyperinflation, a potentially serious side effect of the drug. The FDA has received more than 200 adverse event reports related to hyperinflation since Orbera was first approved in 2015. The FDA is working with the company that manufactures the device, Apollo Endosurgery, to determine the underlying cause of the hyperinflation and potential mitigation strategies.
Cost

The cost of Orbera treatment varies widely depending on where you live and who you choose to have the procedure performed. It can cost anywhere from $3,000 to $9,000, though most patients report a cost of $6,000 to $7,000. The cost of ORBERA treatment is also dependent on the type of treatment you choose and the doctor you choose.

Patients are sedated and undergo a diagnostic endoscopy, which threads a scope down the esophagus and into the stomach. This procedure is not suitable for patients who are pregnant or have certain medical conditions. The balloon is then inflated with saline solution using a syringe. The procedure takes up to six months, and after this time, the balloon is removed.

Because the balloon will remain in the stomach for six months, the patient will feel fuller longer, reducing the amount of food they eat. The Orbera balloon will also slow the digestion process, which allows patients to feel full longer. Usually, the greatest results will occur within the first three months after the procedure. Patients can further boost their weight loss by pairing the balloon with the Orbera Coach tool, which offers a virtual support team through a tablet and a telephone.
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