Viewing Study NCT04607798



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Study NCT ID: NCT04607798
Status: COMPLETED
Last Update Posted: 2020-10-29
First Post: 2020-10-22

Brief Title: Multi-polar RF and PEMF for Treatment of Vulvovaginal Atrophy
Sponsor: Venus Concept
Organization: Venus Concept

Study Overview

Official Title: Clinical Evaluation of the Safety and Efficacy of Using Multi-Polar RF and PEMF Technologies for the Treatment of Symptoms Associated With Vulvovaginal Atrophy
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study evaluates the use of multi-polar radiofrequency RF and pulsed electro-magnetic fields PEMF energies for the treatment of symptoms related to genitourinary syndrome of menopause GSMvulvovaginal atrophy VVA All subjects will receive a total of three internal treatments at four week intervals Subjects will be followed up at one and four months after treatment is complete
Detailed Description: Largely observed in the post-menopausal population a significant subset of pre-menopausal and peri-menopausal women are also affected by symptoms associated with GSM the etiology being similar in that there is an interruption in normal estrogen production resulting in a hypoestrogenic state Symptoms related to GSM include vaginal dryness decreased lubrication decreased vaginal elasticity irritation and discomfort of the vaginal and vulvar tissues in general that can affect sexual health Traditional treatments such as hormone replacement therapy HRT are often the treatment of choice however come with potential risks and many women are not suitable candidates or have contraindications to its use Development of new technologies to address these concerns is warranted

RF energy-based treatment for symptoms of GSM has been used with success to promote elasticity restoration and improve moisture of the vaginal mucosa and is well established in literature for the treatment of facial and neck laxity stress urinary incontinence and skin tightening of tissue Several studies show favorable results with improvement of vaginal laxity and sexual function with RF treatment The addition of pulsed electromagnetic field PEMF energy to multi-polar RF therapy has also been shown to enhance the results of the RF therapy

RF therapy has already been reported to be successful in treatment of symptoms related to elasticity restoration and improve moisture of the vaginal mucosa This study will investigate whether adding PEMF to RF therapy is safe and efficacious for the treatment of symptoms related to GSM and sexual health

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None