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

NCT04737616 | Active Not Recruiting FDA Device

• 1 other identifier: 20195446
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genitourinary Syndrome of Menopause

Keywords

OCT: Optical coherence tomography; CO2: Carbon dioxide; GSM: genitourinary syndrome of menopause; OCE: Optical coherence angiography; OCTA:Optical coherence tomography with angiography

Outcome Measures

Primary Outcomes (1)

• Vaginal epithelial thickness (VET)

  Vaginal epithelium thickness measured with the OCT.

  2 years

Secondary Outcomes (3)

• blood vessel density

  2 years

• Vaginal Health Index (VHI)

  2 years

• Lactobacillus abundance

  2 years

Study Arms (2)

CO2 Laser +OCT

EXPERIMENTAL

Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment

Device: CO2 laser; Device: OCT

OCT only

EXPERIMENTAL

Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan

Device: OCT

Interventions

CO2 laser DEVICE

Fractional CO2 vaginal laser for genitourinary syndrome of menopause

CO2 Laser +OCT

OCT DEVICE

Optical coherence tomography endoscope

CO2 Laser +OCT; OCT only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is for women only as it studies vaginal health.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Felicia Lane, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of FPMRS

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 4, 2021
• Study Start: July 16, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)