Successful pivotal trial for Orbera Intragastric Balloon for weight loss- Apollo Endosurgery
Apollo Endosurgery, Inc.has announced the presentation of results from the Orbera Pivotal Trial at this year�s Digestive Disease Week (DDW) conference. The study showed that Orbera Intragastric Balloon users lost significantly more weight than the control group, leading to significant improvement in weight related quality of life and improved eating behaviors.
In the US pivotal Orbera clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, obese patients 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. More than three-fourths (78.4 percent, 98/125) of the treatment group and 71.5 percent (93/130) of the control group completed the full study at Week 52.
Detailed findings from the trial include: � At month six, the Orbera group achieved a mean of 40 percent Excess Weight Loss (EWL), with 72 percent of Orbera-treated patients achieving at least 25 percent EWL � Mean Total Body Weight Loss (TBWL) at six months was 10.54 percent for the treatment group compared to 4.71 percent TBWL for the control group. The Orbera group lost over twice as much weight as the control group at six months. � The Orbera group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, six months after removal of the device.
Comment:Apollo Endosurgery acquired rights to the Orbera intragastric balloon with the rest of Allergan�s obesity business. ReShape Medical recently announced completion of a successful pivotal, sham-controlled study of their intragastric balloon for obesity treatment and has filed for FDA approval. Allurion Technologies is yet another, early-stage company with a unique intragastric balloon device under development.
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