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NOT YET RECRUITING
NCT06768073
NA

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

Sponsor: AVeta Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-03

Completion Date

2025-11-03

Last Updated

2025-01-10

Healthy Volunteers

No

Interventions

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.

Locations (2)

IMA Clinical Research,

Warren Township, New Jersey, United States

Pineo Clinic (Pineo Medical Ecosystem)

Tbilisi, Georgia