08.28.15
Apollo Endosurgery Inc. has achieved some heavy-hitting clinical results with its ORBERA Intragastric Balloon.
Results from the ORBERA pivotal trial 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.
“At the completion of the study, it was clear that the ORBERA Intragastric Balloon produced significant weight loss and quality of life benefits, when compared to the study’s control group,” said Barham Abu Dayyeh, M.D., gastroenterologist and advanced endoscopist at The Mayo Clinic in Rochester, Minn. “The results of this study prove that ORBERA can be an outstanding tool to aide weight loss and support sustainable, healthy habits, even after it has been removed.”
In the U.S. pivotal ORBERA clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, obese patients with a body mass index 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 six 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 six, with regular office visits continuing through one 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:
Based in Austin, Texas, Apollo Endosurgery develops minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures. Apollo Endosurgery was cofounded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the University of Texas Medical Branch and the Chinese University of Hong Kong. This collaboration developed a broad portfolio of patents in the field of endoscopic surgery that became the foundation of Apollo Endosurgery.
Results from the ORBERA pivotal trial 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.
“At the completion of the study, it was clear that the ORBERA Intragastric Balloon produced significant weight loss and quality of life benefits, when compared to the study’s control group,” said Barham Abu Dayyeh, M.D., gastroenterologist and advanced endoscopist at The Mayo Clinic in Rochester, Minn. “The results of this study prove that ORBERA can be an outstanding tool to aide weight loss and support sustainable, healthy habits, even after it has been removed.”
In the U.S. pivotal ORBERA clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, obese patients with a body mass index 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 six 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 six, with regular office visits continuing through one 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; and
- 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.
Based in Austin, Texas, Apollo Endosurgery develops minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures. Apollo Endosurgery was cofounded with the Apollo Group, a unique collaboration of physicians from the Mayo Clinic, Johns Hopkins University, Medical University of South Carolina, the University of Texas Medical Branch and the Chinese University of Hong Kong. This collaboration developed a broad portfolio of patents in the field of endoscopic surgery that became the foundation of Apollo Endosurgery.