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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: CO2 laser; Device: OCT

Detailed Description

The 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: To determine the feasibility and sensitivity of the integrated optical coherence endoscope to assess vaginal tissue integrity in pre, peri and postmenopausal women

We will enroll up to 90 women (age: 18 and older) who will be classified as pre-menopausal, peri- menopausal, or post-menopausal. There will be 30 women in each group. All enrolled subjects will first complete informed consents.

They will then fill out a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health. This will be followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome .

This will be followed by OCT scan of the vaginal tissue. There will be only one visit.

Aim 2: To optically visualize the effects of fractional-CO2 laser treatment on vaginal tissue over the course of C02 vaginal laser therapy.

Up to thirty Post-menopausal subjects with GSM who desire fractional-CO2 laser therapy, will be recruited.

Each visit will include: completion of a questionnaire (the vulvovaginal symptom questionnaire) about their vaginal health; followed by a pelvic exam to determine the vaginal health (vaginal health index) and to obtain a vaginal swab for assessment of the vaginal microbiome and an OCT scan of the vaginal tissue before the CO2 vaginal laser treatment.

This group will have a total of three visits with CO2 laser treatments. There will be a fourth visit which will include all the above study procedures except the CO2 laser treatment.

Subjects who complete 3 laser treatments will be offered participation in long term follow up with repeat OCT imaging every 3 months at 3, 6, 9 and 12 months after the final laser treatment to study the long- term effects of the laser treatment on the vaginal tissue.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Beckman Laser Institute and Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

Aim 1:

. Women who are premenopausal, peri-menopausal and postmenopausal

Aim 2:

. Postmenopausal women with genitourinary syndrome of menopause

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CO2 Laser +OCT; Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment	Device: CO2 laser; Fractional CO2 vaginal laser for genitourinary syndrome of menopause; Device: OCT; Optical coherence tomography endoscope
Experimental: OCT only; Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan	Device: OCT; Optical coherence tomography endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal epithelial thickness (VET)	Vaginal epithelium thickness measured with the OCT.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood vessel density	The blood vessel density will be measured by OCT	2 years
Vaginal Health Index (VHI)	VHI to be measured on exam	2 years
Lactobacillus abundance	Lactobacillus abundance by RNA sequencing	2 years

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Felicia Lane, MD, UC Irvine

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: OCT: Optical coherence tomography; CO2: Carbon dioxide; GSM: genitourinary syndrome of menopause; OCE: Optical coherence angiography; OCTA:Optical coherence tomography with angiography
• Other Study ID Numbers: 20195446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No