Viveve Medical (NSDQ:VIVE) announced that it completed enrollment in a short-term feasibility study for its cryogen-cooled monopolar radiofrequency (CMRF) treatment for stress urinary incontinence (SUI) in women.
The international, three-arm study is a prospective, randomized, single-blind clinical trial comparing Viveve’s CMRF treatment and a cryogen-only sham to an inert sham treatment in women with SU. Englewood, Colo.-based Viveve enrolled approximately 12 subjects across three clinical sites in Canada on a 1:1:1 ratio to each of the three arms.
According to a news release, the primary efficacy endpoint of the study is a mean change from baseline in the standardized one-hour pad weight test at three months post-treatment. Additional endpoints include the 24-hour pad weight test and a three-day voiding diary at three months post-treatment.
Viveve’s FDA-cleared CMRF technology is designed to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session.
“Completion of enrollment in our short-term feasibility study is an important milestone in our SUI clinical development program. We are pleased that enrollment was achieved expeditiously by our clinical trial sites. We look forward to the results of this study in the third quarter 2020,” said Scott Durbin, Viveve’s chief executive officer.
“SUI is a condition that affects an estimated 25-30 million women worldwide,” Viveve CEO Scott Durbin said in a news release. “We believe that our single-session procedure may offer women the potential for significant improvement in urine leakage and the ability to engage in their daily lives with greater comfort and control. We are hopeful that the results will enable the resubmission of our investigational device exemption to the [FDA] to conduct a pivotal clinical trial for SUI in the [U.S].”
