NCT06768073

Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)

Clinical Outcomes and Safety of an Intravaginal Negative Pressure Medical Device in the Treatment of Genitourinary Syndrome of Menopause (GSM): A Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AVeta Medical · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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 infections screening test (gonorrhea, chlamydia, bacterial vaginosis, trichomonas and yeast) * Pregnancy Test * Vaginal Health Index (VHI) Score. * Vaginal pH. * Clinical examination to confirm that the vaginal canal is free of any lesions other than symptoms of GSM. * Self-assessment of symptoms related to GSM and confirmation of moderate to severe dyspareunia. All screening information necessary to evaluate whether the subject meets the inclusion/exclusion criteria should be available and reviewed prior to treatment. Subjects who do not meet the eligibility criteria upon screening will be considered screening failures. Screening failures will not be followed further except in case of adverse events occurring at the screening visit. In this case, subjects will be monitored until the adverse event(s) are resolved. The eligible subjects will be randomized and introduced to the treatment at the first treatment visit. Treatment Visits The following are completed prior to treatment: 1. Pre-Treatment Assessments * Urinary Tract Infection Test. * Vaginal pH. * Vaginal moisture (modified Schirmer Test). * Vaginal Maturation Index (VMI) Score. * Clinical Examination - Immediately prior to each treatment, a visual examination of the vulvo-vaginal area is carried out. The appearance of the vaginal mucosa before each treatment will be assessed (by the same investigator for each subject) taking parameters of Vaginal Mucosa Assessment (VMA) into account. * Vaginal Health Index (VHI) Score. * Imaging of Vaginal Wall - An image of the mucosa will be taken after the clinical examination and prior to each treatment. * Self-assessment of symptoms related to GSM and confirmation of moderate to severe dyspareunia. * Female Sexual Function Index (FSFI) questionnaire. 2. Randomization Before initiating treatment, subjects continuing to meet eligibility criteria will be randomized to one of following two arms: * VITA AV Clinical System (active treatment). * Sham device. Each active treatment is delivered at a negative pressure of 460 mmHg for 5 minutes. After the treatment, the clinician will re-assess the vaginal mucosa to review the induced micro-trauma, if any. This appears as visible dome shaped effects on the vaginal mucosa corresponding to the apertures in the intravaginal tip. They may appear red indicating induced petechiae, which is the desired response. Images will be taken after each treatment to record the treatment effect at site # 2. After the initial treatment, each subject returns for an additional 3 treatments performed at 4-week intervals (+/-4 days) for a total of four treatments. In addition, the following are assessed, as part of the clinical examination, prior to performing subsequent treatments to ensure that the vaginal canal is free from: 1. bleeding, 2. inflammation, 3. the desired microtrauma effects of any previous treatment. 4. other abnormal effects. Follow-Up Visits: Will occur at 1-, 3- post the last treatment will take place for all subjects. Will occur at 6-, 9- and 12-months post the last treatment will take place for subjects in the Active treatment only. Note: The 9-month follow-up visit will be conducted via phone call.

Conditions

• Genitourinary Syndrome of Menopause

Interventions

Type	Name	Description
DEVICE	Sham (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.

Timeline

• Start date: 2025-03-03
• Primary completion: 2025-11-03
• Completion: 2025-11-03
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

2 sites across 2 countries: United States, Georgia

Regulatory

• FDA-regulated device study