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

Part of paid clinical trials in Warren Township, New Jersey.

Sponsor
AVeta Medical
Study ID
NCT06768073
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sham (No Treatment) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Jan 2025
Primary completion
Nov 3, 2025
Completion
Nov 3, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment
    The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a white connector component, part number 10531-01, to allow the vacuum to be delivered to the vaginal tissue when then vacuum pump is activated.
  • Sham Comparator: Sham Treatment
    The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a black connector component, part number 10531-02, to block and prevent the vacuum from being delivered to the vaginal tissue when then vacuum pump is activated.

Primary Outcome Measure

Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment. [ Time Frame: Baseline to 3-months post the last treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IMA Clinical Research,Warren TownshipNew Jersey07059
Nancy Philips (PRINCIPAL_INVESTIGATOR)

Find similar trials in Warren Township, NJ

By condition
Menopause
By specialty
Women's healthFertility
By research site
IMA Clinical Research· Warren Township, NJ

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