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

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ClinicalTrials.gov Identifier: NCT04737616
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Felicia Lane, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Genitourinary Syndrome of Menopause Device: CO2 laser Device: OCT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Vaginal epithelial thickness (VET) [ Time Frame: 2 years ]
    Vaginal epithelium thickness measured with the OCT.


Secondary Outcome Measures :
  1. blood vessel density [ Time Frame: 2 years ]
    The blood vessel density will be measured by OCT

  2. Vaginal Health Index (VHI) [ Time Frame: 2 years ]
    VHI to be measured on exam

  3. Lactobacillus abundance [ Time Frame: 2 years ]
    Lactobacillus abundance by RNA sequencing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The study is for women only as it studies vaginal health.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737616


Contacts
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Contact: Afiba Arthur, MD 9497524700 raarthur@hs.uci.edu

Locations
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United States, California
UC Irvine Recruiting
Costa Mesa, California, United States, 92626
Contact: Afiba Arthur    949-752-4700    raarthur@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Felicia Lane, MD UC Irvine
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Responsible Party: Felicia Lane, Chair, division of FPMRS, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04737616    
Other Study ID Numbers: HS# 2019-5446
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes