ReShape Medical® Inc announced today that it has completed enrollment in the pivotal clinical trial for the ReShape Duo® Intragastric Balloon, one of the first non-surgical weight loss devices developed for the U.S. market. The ReShape Duo is placed in the stomach using a standard endoscope, with no incisions or sutures, where it takes up much of the stomach’s volume causing patients to eat smaller portions and to feel full sooner. Over the six month placement period, the ReShape Duo is designed to help patients consistently lose weight while facilitating new eating and lifestyle behaviors for long-term weight maintenance.
The eight participating sites were able to recruit and enroll 326 subjects in less than six months. “There is tremendous patient interest in a non-surgical approach to weight loss,” said George Woodman, MD, Memphis, Tennessee, the highest enrolling investigator involved in the trial. “We had many more potential subjects than we could actually enroll.”
The REDUCE Trial
The pivotal trial is a randomized, sham controlled design. Study endpoints assess weight loss, responder rates and duration of effect. “This is the first non-surgical weight loss device to be studied since the FDA announced their risk stratified approach to weight loss products,” said Jaime Ponce, MD, Dalton, Georgia, Principal Investigator in the REDUCE trial. “We’re very enthusiastic about its potential to help patients lose significant weight, without surgery.”
The trial design included an interim analysis that allows an independent statistician to evaluate whether the study required additional enrollment to maintain the planned study power. “The interim analysis was recently completed and showed that there was no need to increase enrollment,” said Mary Lou Mooney, VP Clinical, Regulatory and Quality. “We can now complete the study on time and with greater confidence in a positive outcome.”
About ReShape Medical, Inc.
ReShape Medical® (www.reshapemedical.com) is a medical device manufacturer headquartered in Southern California. The company specializes in a dual-intragastric balloon for weight loss, ReShape Duo®, to be used as an aid in the treatment of obese or overweight patients. ReShape Duo is a non-surgical alternative designed for those who have exhausted their efforts with diet alone and wish to avoid or do not qualify for surgery. It comfortably occupies existing space in the stomach for six months, serving as built in portion control, to help patients feel full and satisfied with less food. The product has been available in the European Union since December 2011. CAUTION: Investigational Device. Limited by Federal (United States) law to investigational use.