Viveve submits VIVEVE II clinical study patient safety data to FDA.
Viveve Medical announced that it has submitted 30-day patient safety data to the U.S. Food and Drug Administration for 38 subjects completing the 1-month assessment in the company's multicenter randomized Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy clinical study. VIVEVE II is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 250 subjects at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments. A staged approach for clinical enrollment was required by the FDA in its Investigational Device Exemption approval letter to the company on March 19, 2018. In the first stage, enrollment is limited to 50 subjects and requires safety review by the FDA of a minimum of 25 subjects at one-month post-treatment. The primary efficacy endpoint is intended to be the mean change from baseline in the total FSFI at 12 months. Subjects will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints measured at six months post-treatment that address the efficacy of and improvement in FSFI domain scores for Desire, Lubrication, Orgasm, Arousal, Satisfaction, and Pain.
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|Article Type:||Clinical report|
|Date:||Jul 3, 2018|
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