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

NCT03725410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-06-02

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Atrophy

Interventions

DEVICE

Venus Fiore Study Treatment

Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).

DEVICE

Venus Fiore Sham Treatment

Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Matthew Gronski, PhD · Venus Concept Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725410 on ClinicalTrials.gov