Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy
Running, not enrolling · Not applicable
Conditions studied: Genitourinary Syndrome of Menopause
In brief
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.
Key facts
- Study ID
- NCT04737616
- Run by
- University of California, Irvine
- People needed
- 90
- Starts
- 2020-07-16
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Aim 1:
- . Women who are premenopausal, peri-menopausal and postmenopausal
- Aim 2:
- . Postmenopausal women with genitourinary syndrome of menopause
You may not qualify if…
- history of pelvic irradiation
- Current pregnant or breastfeeding
- Use of hormone replacement therapy within three months of study enrollment
- Inability to read and understand english
- inability to follow research instructions
Where it is running
- Beckman Laser Institute and Medical Clinic — Irvine, California, United States
Full record on ClinicalTrials.gov
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