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

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 4, 2019

Primary Completion Date

September 30, 2022

Study Completion Date

December 31, 2022

Conditions
Vulvovaginal AtrophyMenopauseMenopause 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)."

Trial Locations (1)

L6B 0T1

Dr. George Arnold, Markham

All Listed Sponsors
lead

Venus Concept

INDUSTRY

NCT04210583 - RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity | Biotech Hunter | Biotech Hunter