New Non-Hormonal Treatment by Radiofrequency for Vulvo-Vaginal Atrophy
Status:
Recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Vulvo-Vaginal Atrophy (VVA) or Genitourinary Syndrome of Menopause (GSM) is a common and
under-reported condition associated with decreased estrogenization of the vaginal tissue The
aim of this study is to evaluate safety and efficacy of " Dynamic Quadripolar
Radio-frequency" thermal treatment with Vaginal Dynamic Radio-frequency (VDR™) and
Radio-frequency Safety System (RSS™) for the treatment of VVA and GSM in postmenopausal women
who either present contra-indication for menopause hormone therapy, or are not willing to use
Menopause Hormone Therapy (MHT) or have failed to be helped using MHT.
Phase:
N/A
Details
Lead Sponsor:
Serge Rozenberg
Collaborators:
Centre Hospitalier Universitaire Brugmann Erasme University Hospital Hôpitaux IRIS Sud Jules Bordet Institute NOVAVISION GROUP S.P.A