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Multi-polar RF and PEMF for Treatment of Symptoms Associated With Vulvovaginal Atrophy

Vulvovaginal Atrophy Clinical Trial

Official title:
Clinical Evaluation of the Safety and Performance of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy

Clinical Trial Summary

This is a multicenter, single-blind, randomized, sham-controlled study utilizing the Venus Fiore™ (MP)2, a table-top device designed to deliver multi-polar RF energy and pulsed electromagnetic fields for use in dermatological and general surgical procedures to temporarily improve blood circulation and to induce modification of collagen structure, neocollagenesis and angiogenesis for the treatment of symptoms associated with vulvovaginal atrophy.

Clinical Trial Description

Multicenter, single-blind, randomized, sham-controlled study of multi-polar radio-frequency (RF) and pulsed electro-magnetic field (PEMF) technologies for the treatment of symptoms associated with vulvovaginal atrophy. The study will enroll up to 106 subjects requesting treatment of symptoms of vulvovaginal atrophy (vaginal dryness, decreased lubrication during sexual activity, decreased elasticity, irritation, discomfort during intercourse and discomfort of the vaginal and vulvar tissues in general) in order to have 88 subjects complete the study. Subjects will be randomized in a 1:1 ratio to either multi-polar RF and PEMF technologies or sham treatment and will receive a total of three internal and external treatments with the Venus Fiore™ (MP)2 device at four-week intervals. Study treatment will be administered as per the parameter recommendations as set out in the Venus Fiore™ (MP)2 user manual. Subjects will be followed up at three and six months after their initial treatment. Analysis will be performed on all subjects who receive at least one treatment. Three- and six-month outcomes from the active arm will be compared to data from the sham arm. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03725410
Study type Interventional
Source Venus Concept
Contact
Status Completed
Phase N/A
Start date September 25, 2018
Completion date December 31, 2022
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