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RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity

NCT04210583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-06-02

No results posted yet for this study

Summary

Twelve month extension of a previous study of Multi-Polar RF and PEMF technologies for the treatment of vaginal laxity and for the treatment of the mons pubis and labia for improvement in skin laxity. The study will enroll up to 50 subjects who completed the Venus Fiore CS0716 study for the treatment of vaginal laxity and treatment of the mons pubis and labia for improvement in skin laxity. Subjects will be followed up at least six and twelve months post-treatment. Analysis will be performed on all subjects who complete the six-month and twelve month follow-up visits.

Conditions

  • Vulvovaginal Atrophy
  • Menopause
  • Menopause Surgical

Interventions

DEVICE

Vulvovaginal Treatment

Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment). Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment). Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment). Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment).

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Mathew Gronski · Venus Concept

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04210583 on ClinicalTrials.gov