Enrollment for ENLIGHTEN, a United States clinical trial for the Elipse® Balloon – the world’s first and only procedureless™ gastric balloon for weight loss, has started at University of Colorado Hospital at the CU Anschutz Medical Campus.
The study is designed to evaluate the safety and efficacy of the Elipse Balloon in 400 individuals. It is administered by Allurion Technologies, a leader in the development of weight loss therapies. The study will be conducted at up to twelve sites in the United States. Dr. Shelby Sullivan, associate visiting professor of gastroenterology at the CU School of Medicine and a specialist in endoscopic bariatric weight-loss procedures is leading the trial in Colorado.
“We are excited to be the only center in Colorado enrolling patients in the ENLIGHTEN study, the first completely procedureless gastric balloon for weight loss,” Sullivan said. “A device like this which doesn’t require a procedure will lower the barriers for patients who need help with weight loss.”
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. Unlike other weight loss balloons, the Elipse Balloon is 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.
“We are looking forward to adding to our global clinical trial experience with the Elipse Balloon,” said Ram Chuttani, M.D., Chief Medical Officer of Allurion. “Starting ENLIGHTEN is the first step toward bringing our flagship product to the United States where we can build upon the success we have had abroad.”
“The Elipse Balloon has the potential to revolutionize the way obesity is treated in the United States,” added Shantanu Gaur, M.D., 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 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 demonstrated an average weight loss of 29 to 33 pounds, approximately 15% of total body weight. Participants also saw improvements in their triglycerides, hemoglobin A1c (HbA1c) and quality of life.
Study visits will occur at the CU Anschutz Health and Wellness Center. Interested participants can learn more about the study, eligibility and how to register at http://balloontrial.com and http://clinicaltrials.gov/ct2/show/NCT03261453.
Image Source: Allurion Technologies