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

NACompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 3, 2018

Primary Completion Date

March 31, 2022

Study Completion Date

December 31, 2022

Conditions
Vulvovaginal AtrophyMenopauseMenopause Surgical
Interventions
DEVICE

Vulvovaginal treatment

"* Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.~* Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.~* Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes."

DEVICE

Baseline

Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.

Trial Locations (3)

V4B 5C9

Southern Health Centre, White Rock

L6B 0T1

Dr. George Arnold, Markham

M4T 2A2

Pearl MD Rejuvenation, Toronto

All Listed Sponsors
lead

Venus Concept

INDUSTRY

NCT03536585 - Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity | Biotech Hunter | Biotech Hunter