๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-16

Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy (NCT04737616)

Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: University of California, Irvine

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

We have recently developed and optimized a vaginal Optical Coherence tomography/angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria. The primary focus of this study is establishing the Optical Coherence Tomography system's capability of capturing vaginal changes that occur before and after menopause, as well as before and after treatment with fractional-CO2 laser therapy. There are two aims of this study. Aim 1: 1\. To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women. Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.

Who can join: Review the eligibility criteria below.

Location: Beckman Laser Institute and Medical Clinic โ€” Irvine, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Beckman Laser Institute and Medical Clinic โ€” Irvine, California

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—