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ENLIGHTEN Elipse Balloon study

Allurion initiates ENLIGHTEN trial for Elipse Balloon

First patients treated in the US with the world’s first and only procedureless gastric balloon for weight loss

Allurion Technologies has started the ENLIGHTEN clinical trial for the Elipse Balloon – the world’s first and only procedureless gastric balloon for weight loss. ENLIGHTEN is a randomised, sham-controlled study designed to evaluate the safety and efficacy of the Elipse Balloon in 400 individuals. The study will be conducted at up to 12 sites in the US.

Unlike other weight loss balloons on the market, the Elipse Balloon is placed and removed without surgery, endoscopy or anaesthesia. 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.

Jamie Ponce

“The start of the ENLIGHTEN clinical trial is not only a milestone for the Elipse Balloon, but also for the field of weight loss more broadly,” said Dr Jaime Ponce, Medical Director of Chattanooga Memorial Hospital Weight Management Center and Principal Investigator of the ENLIGHTEN study. “Non-surgical weight loss therapies will help treat those who have not seen success from dieting alone. Having now treated the first patients in ENLIGHTEN, we are one step closer to having a next-generation tool to offer those in need of a solution.”

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. Participants also saw improvements in their triglycerides, hemoglobin A1c (HbA1c) and quality of life.

“We are looking forward to adding to our global clinical trial experience with the Elipse Balloon,” said Dr Ram Chuttani, Chief Medical Officer of Allurion. “Starting ENLIGHTEN is the first step toward bringing our flagship product to the US where we can build upon the success we have had abroad.”

The Elipse Balloon received its European Union CE mark in 2015 and is currently available in more than 40 weight loss centers in countries across Europe and the Middle East. Over 4,000 individuals have already been treated.

“The Elipse Balloon has the potential to revolutionize the way obesity is treated in the US,” added Dr Shantanu Gaur, Chief Executive Officer of Allurion. “Millions of Americans are struggling to lose weight, and they are calling for new options that are safe and effective. The ENLIGHTEN study is the next step in meeting this consumer need.”

The Elipse System is not yet approved by the FDA and is not currently available commercially in the US. 

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