NATICK, Mass.--(BUSINESS WIRE)--Allurion Technologies, a pioneering leader in the development of innovative, scalable and trusted weight loss experiences, today announces completion of enrollment in ENLIGHTEN, a United States clinical trial for the Elipse® Balloon –a procedureless™ gastric balloon for weight loss. Allurion expects to use the data from this trial in its future regulatory submission to the U.S. Food and Drug Administration (FDA).
“We have been encouraged by the performance of the Elipse Balloon thus far,” said Jaime Ponce, M.D., Medical Director of Chattanooga Memorial Hospital Weight Management Center and Principal Investigator of the ENLIGHTEN study. “A weight loss device that does not require surgery, endoscopy, or anesthesia could be an appealing option for millions of people in need of care.”
The trial has been met with extraordinary interest in the United States. More than 62,000 individuals visited the ENLIGHTEN trial website since the first patients were treated on February 1, 2018. In total, more than 400 patients were enrolled in 11 centers throughout the United States.
“Our experience to date with the Elipse Balloon underscores its potential convenience, ease of use, and scalability,” said Rachel L. Moore, M.D., F.A.C.S. of Surgical Specialists of Louisiana in New Orleans. “Unlike some other weight loss interventions, Elipse requires no endoscopy, which could make it very popular with both doctors and patients.”
The Elipse Balloon received its European Union CE mark in 2015 and is currently available in more than 100 weight loss centers in countries across Europe and the Middle East. More than 6,000 individuals have already been treated. Unlike other weight loss balloons on the market, the Elipse Balloon can be placed and removed without surgery, endoscopy, or anesthesia. It is swallowed in a capsule during a brief outpatient office visit and remains in the stomach for approximately four months, after which it opens and passes naturally from the body.
“The remarkable demand we observed during enrollment supports the consumer-facing approach we took in the design of the Elipse Balloon,” said Ram Chuttani, M.D., Chief Medical Officer of Allurion. “With enrollment behind us, we are looking forward to receiving top-line results early next year.”
About the ENLIGHTEN Study
ENLIGHTEN is a randomized, sham-controlled study designed to evaluate the safety and efficacy of the Elipse Balloon in 400 individuals. For more information, please visit: http://clinicaltrials.gov/ct2/show/NCT03261453.
About the Elipse Balloon
The Elipse Balloon is a procedureless weight loss device that is swallowed and removed without surgery, endoscopy, or anesthesia. The Elipse System received its European Union CE mark in 2015 and is currently available in Europe and the Middle East. It is not approved by the FDA and is not currently available commercially in the United States.
The Elipse Balloon is made of a thin, flexible polymer film. The device is swallowed in a capsule and filled with liquid through a thin delivery catheter, which is then detached. The balloon remains in the stomach for approximately four months, after which it opens, allowing it to empty and pass naturally from the body without the need for a removal procedure. A pilot clinical study and recent 135-patient clinical trial conducted outside the United States in overweight and obese individuals demonstrate an average weight loss of 13 to 15 kilograms (29 to 33 pounds), which equates to approximately 15% of total body weight.1,2 Participants also saw improvements in their triglycerides, hemoglobin A1c (HbA1c) and quality of life.1
About Allurion Technologies
Allurion Technologies is dedicated to helping people realize their full potential with innovative, scalable and trusted experiences. The company's flagship product, the Elipse Balloon, is the world’s first and only swallowable, procedureless gastric balloon for weight loss. Learn more about the Elipse Balloon and Allurion online at www.allurion.com, on Facebook at www.fb.com/allurion or on Twitter @alluriontech.
|1.||Raftopoulos and Giannakou. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13:1174-1182.|
|2.||Al Sabah et al. The safety and efficacy of the procedure-less intra-gastric balloon. Surg Obes Relat Dis. doi:10.1016/j.soard.2017.12.001.|