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Radiofrequency and Pulsed Electromagnetic Field Energies
Multi-polar RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
White Rock, Canada
N/A
Waitlist Available
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
No Placebo-Only Group
Summary
The study evaluates the use of multi-polar radiofrequency (RF) and pulsed electro-magnetic fields (PEMF) energies for the treatment of vaginal looseness and for the treatment of the mons pubis and labia for skin tightening. All subjects will receive a total of three internal and three external treatments at four week intervals. Subjects will be followed up at one and four months after treatment is complete.
See full description
Eligible Conditions
- Menopause
- Vulvovaginal Atrophy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Vaginal Laxity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vulvovaginal treatmentExperimental Treatment2 Interventions
Internal vaginal treatment monthly for 3 treatments; External mons pubis treatment monthly for 3 treatments; External labia treatment monthly for 3 treatments.
Group II: BaselineActive Control1 Intervention
Subject's baseline photograph to act as their own control for the one-month and four-month post-treatment photograph of the mons pubis and labia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vulvovaginal treatment
2018
N/A
~70
Baseline
2024
Completed Phase 2
~370
Find a Location
Closest Location:Southern Health Centre· White Rock, Canada
Who is running the clinical trial?
Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,261 Total Patients Enrolled
2 Trials studying Menopause
50 Patients Enrolled for Menopause
Paul CardarelliStudy DirectorVenus Concept
1 Previous Clinical Trials
50 Total Patients Enrolled