US-based medical device manufacturer ReShape Medical has finished enrolling patients in a randomised, pivotal clinical trial of its non-surgical weight loss device for the treatment of obesity.
The sham-controlled design of the trial includes an interim analysis, which allowed an independent statistician to evaluate whether the study required additional enrolment to maintain the planned study.
ReShape clinical, regulatory and quality VP Mary Lou Mooney said the interim analysis was complete and showed that there was no need to increase enrolment.
"We can now complete the study on time and with greater confidence in a positive outcome," Mooney said.
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 the endpoints of the study.
Using a standard endoscope, the ReShape Duo intragastric balloon is placed in the stomach with no incisions or sutures for six months, where it serves as a built-in portion control to help patients to eat smaller amounts and feel full sooner.
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 said.
Available in the European Union, the company said the device is limited by federal law to investigational use in the US.