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Hedden and Gunn Plastic Surgery
140 Village St., Ste. 100
Birmingham, AL 35242
205-980-1744
Birmingham, Alabama Gastric Balloon Weight Loss System Orbera managed weight loss system

Orbera Clinical Trial

Gastric balloon in stomach

In the U.S. pivotal ORBERA™ clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the Orbera balloon followed by removal after 6 months. They concurrently participated in a 12-month behavioral modification program. The control group participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month 6, with regular office visits continuing through 1 year.

A total of 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.

Detailed findings from the trial include: