Intravaginal Negative Pressure Medical Device for Treatment of Genitourinary Syndrome of Menopause (GSM) (NCT06768073)
Clinical Outcomes and Safety of an Intravaginal Negative Pressure Medical Device in the Treatment of Genitourinary Syndrome of Menopause (GSM): A Pilot Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: IMA Clinical Research, — Warren Township, New Jersey
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- IMA Clinical Research, — Warren Township, New Jersey
- Pineo Clinic (Pineo Medical Ecosystem) — Tbilisi,
📞 Contact the Study Coordinator
Phone: +353 87 248 3582
Email: orla@avetamedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Genitourinary Syndrome of Menopause
- Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy — Irvine, California
- Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause — Laguna Hills, California
- Vaginal Changes After CO2 Laser — Irvine, California
Explore by condition: All Genitourinary Syndrome of Menopause clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.