Clinical Outcomes and Safety of an Intravaginal Negative Pressure Medical Device in the Treatment of Genitourinary Syndrome of Menopause (GSM): A Pilot Study
AVeta Medical
Summary
This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.
Description
There will be up to 6 in-person visits (screening visit, 4 treatment visits and 2 follow-up visits) for all subjects. Screening After signing the informed consent form, subjects will be screened to ensure they meet the inclusion and exclusion criteria before initiating treatment. Screening includes collecting information from the patient history (medical history, demographics and medications) as well as conducting the following clinical assessments: * Dilator suitability. * Papanicolaou Test (current within last year or repeated within 2 weeks of initial treatment). * Sexually transmitted i…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Healthy postmenopausal subjects from 1 to 15 years since their last menstrual cycle. 2. Willingness to refrain from using alternative therapies for treatment of symptoms of GSM, unless medically necessary, through the duration of this study. 3. Moderate to severe dyspareunia associated with GSM. (i.e., ≥4 on the 11-point patient-reported numeric rated dyspareunia scale). 4. Subjects who are sexually active (i.e. have had or have attempted to have sexual activity with vaginal penetration within approximately 1 month of screening visit). 5. Subjects who anticipate engagin…
Interventions
- DeviceSham (No Treatment)
The Sham device is identified to the Active device with the exception that it has a black connector component, part number 10531-02, to block the vacuum from reaching the vaginal tissue with vacuum pump activation. In this manner, the control procedure has been designed to mimic the active therapy to the extent practicable allowing for subject blinding.
Locations (2)
- IMA Clinical Research,Warren Township, New Jersey
- Pineo Clinic (Pineo Medical Ecosystem)Tbilisi