VITA AV Clinical System for Genitourinary Syndrome of Menopause
This study is testing a new medical device called the VITA AV Clinical System to see if it's safe and effective for treating Genitourinary Syndrome of Menopause (GSM). GSM can cause symptoms like vaginal dryness and painful intercourse (dyspareunia). You might be able to join if you are a healthy postmenopausal woman, 1 to 15 years past your last period, and experience moderate to severe pain during intercourse due to GSM. The researchers will compare the VITA AV Clinical System to a sham device (one that looks real but doesn't deliver treatment) to see if it improves vaginal moisture and cell health. The study is currently recruiting participants.
- Study design
- This is an interventional study comparing the VITA AV Clinical System to a sham device, with a planned enrollment of 60 women.
- What's involved
- You would have up to 6 in-person visits, including screening, 4 treatment visits, and 2 follow-up visits. These visits involve medical history, clinical assessments, and tests like a Pap test and STI screening.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will evaluate safety and performance for up to 3 months after your last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM)
At a glance
Conditions
NCT06768073
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
IMA Clinical Research,
Warren Township, New Jerseyno site contact published
Pineo Clinic (Pineo Medical Ecosystem)
Tbilisi, Georgiano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Nancy Philips · PRINCIPAL_INVESTIGATOR · IMA Clinical Research
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety Evaluation of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.Baseline to 3-months post the last treatment.
Safety will be assessed by monitoring all adverse events, with particular attention to serious adverse events (SAEs) related to the device or procedure.
- Percentage of Vaginal Superficial Cells to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.Baseline to 3-months post the last treatment.
Quantified using cytological analysis to determine the percentage of superficial cells. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
- Vaginal Moisture Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.Baseline to 3-months post the last treatment.
Measured using the modified Schirmer Test to assess changes in vaginal hydration levels. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.
- Vaginal pH Levels to evaluate the performance of the VITA AV Clinical System compared to a sham device from baseline to 3-months post the last treatment.Baseline to 3-months post the last treatment.
Measured by inserting a cotton swab vaginally, and applying it to the vaginal pH strip to determine changes in vaginal acidity. Changes will be assessed from baseline up to 3 months following the last treatment. To minimize bias, the clinical exams conducted at the 1-month and 3-month post-treatment visits will be performed by a physician blinded to randomization assignment.