The new Liberate trial will look to enroll 100 subjects at up to 10 sites in Canada, with patients randomized in a two-to-one ratio for active and sham treatments.
The Englewood, Colo.-based company said that the first subject in the trial has had their first visit under an approved Investigational Testing Application with the Canadian Ministry of Health and central investigatioal review board approval.
“Initiation of Liberate-International represents a significant advance in our pursuit of regulatory clearances for the treatment of SUI, a condition that effects an estimated 25-30 million women worldwide. Our single-session procedure offers women the potential for significant improvement in urine leakage and quality of life. The results of Liberate-International, if successful, could support multiple international clearances for use of our CMRF technology in the treatment of SUI around the world, including Health Canada and CE Mark clearances, among others. It is our belief that these clearances demonstrate continued regulatory confidence in the safety of our procedures and CMRF technology. As we continue our commitment towards rapid label expansion, we remain on track to complete the submission of our Investigational Device Exemption to the U.S. Food and Drug Administration for Liberate-U.S., our second SUI registration trial, in the third quarter,” director & CEO Scott Durbin said in a press release.
Last week, Viveve said that it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth.