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ACTIVE NOT RECRUITING
NCT04737616
NA

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2020-07-16

Completion Date

2026-07

Last Updated

2025-07-20

Healthy Volunteers

Yes

Interventions

DEVICE

CO2 laser

Fractional CO2 vaginal laser for genitourinary syndrome of menopause

DEVICE

OCT

Optical coherence tomography endoscope

Locations (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, United States