ReShape Medical has completed patient enrollment in a pivotal clinical trial of its ReShape Duo Intragastric Balloon device, designed for the treatment of obese.
Using a standard endoscope, non-surgical weight loss device is placed in the stomach where it occupies existing space in the stomach for six months and serves as built in portion control to help patients to eat smaller portions and to feel full sooner.
The randomized, sham controlled design of the trial included an interim analysis, which allows an independent statistician to evaluate whether the study required additional enrollment to maintain the planned study.
ReShape Medical clinical, regulatory and quality VP Mary Lou Mooney said the interim analysis was completed and showed that there was no need to increase enrollment.
"We can now complete the study on time and with greater confidence in a positive outcome," Mooney added.
The REDUCE trial, which enrolled 326 patients from eight participating sites, will use the device to assess weight loss, responder rates and duration of effect, which are endpoints of the study.
Trial principal investigator Jaime Ponce said ReShape Duo is the first non-surgical weight loss device to be studied since the FDA announced the risk stratified approach to weight loss products.
"We're very enthusiastic about its potential to help patients lose significant weight, without surgery," Ponce added.
