This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.
Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
LIBERATE In't Site
Vancouver, British Columbia, Canada
LIBERATE Int'l Site
Pointe-Claire, Montreal, Canada
LIBERATE Int'l Site
Burlington, Ontario, Canada
LIBERATE Int'l Site
London, Ontario, Canada
CFB in 1-hour Pad Weight Test
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.
Time frame: 6 months post-treatment
Safety and Adverse Event Reporting
Safety as assessed by Adverse Event reporting
Time frame: 6 months post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
LIBERATE Int'l Site
Sarnia, Ontario, Canada
LIBERATE Int'l Site
Toronto, Ontario, Canada