‘Incisionless’ Investigational Weight-Loss Surgery Study Underway

Scottsdale Healthcare Shea Medical Center is only site in Western U.S. enrolling patients in Essential Trial

Scottsdale Healthcare Shea Medical Center is the only site in the West participating in the Essential Trial, an FDA-approved clinical study to determine the safety and effectiveness of an incision-free, endoscopic weight-loss procedure.

Individuals with a body mass index (BMI) of between 30 and 40 may be eligible for the trial. The incision-free POSE outpatient procedure is performed entirely through the mouth without any incisions through the abdomen.

Physicians participating in the study use an investigational device to place tissue anchors across folds of tissue in strategically located parts of the stomach to reduce its size. The procedure is designed to reduce the stomach’s ability to accommodate and stretch during meals, so the patient can feel full and satisfied with smaller portions.

“This new investigational approach—which is much less invasive than bariatric surgery and performed entirely through the patient’s mouth—may help patients feel full sooner during meals, improving their feelings of fullness and reducing hunger cravings so they can control their portions, consume fewer calories and lose weight,” said Scottsdale Healthcare bariatric surgeon, Jim Swain, M.D.

The Essential Trial is among the largest multicenter studies ever undertaken of an endoscopic approach to primary bariatric surgery, where patients are randomly assigned to one of two groups: the Treatment Group (two in three chance) or the Control Group (one in three chance).

The Treatment Group will undergo the POSE procedure during their endoscopies and the Control Group will not. Both groups will receive the same diet and exercise counseling. At 12 months, the Control Group members may have the opportunity to receive the procedure if they meet the study criteria.

Even though surgery has been proven to be very effective for patients with a BMI greater than 35, fewer than 2 percent of eligible patients choose it as an option.

“The POSE procedure is designed for patients that have a lower BMI but still struggle with their weight and are not eligible for traditional weight loss surgery,” said Dr. Swain. “Nearly 60 million Americans fall into this category, and it is our hope as clinicians to provide options for these patients.”

The POSE procedure has been performed on more than 2,000 patients around the world to date, mainly in Europe. Data from earlier European studies show the investigational procedure helped patients lose, on average, 62 percent of their excess weight after a year. This equates to between 15 percent and 20 percent of their total body weight.

The American Heart Association estimates that 78.4 million Americans age 20 and over are obese (with a BMI of 30.0 kg/m2 and higher). If current trends in the growth of obesity continue, total healthcare costs attributable to obesity could reach $861 to $957 billion by 2030, which would account for 16 percent to 18 percent of U.S. health expenditures, the AHA predicts.

To learn more about eligibility to enroll in the study or for additional information, visit EssentialTrial.com or call the Scottsdale Healthcare Research Institute at 480-323-1292.