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Search / Trial NCT04737616

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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Feb 1, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Oct: Optical Coherence Tomography Co2: Carbon Dioxide Gsm: Genitourinary Syndrome Of Menopause Oce: Optical Coherence Angiography Octa:Optical Coherence Tomography With Angiography

ClinConnect Summary

This clinical trial is studying a new imaging technology called Optical Coherence Tomography (OCT), which helps doctors see detailed images of the vaginal tissues. The purpose of the study is to understand how the vagina changes before and after menopause and how effective a specific treatment, called fractional-CO2 laser therapy, is for women experiencing issues related to menopause. The researchers want to see if this imaging system can accurately assess the health of vaginal tissues in women who are at different stages of menopause and how the laser treatment affects those tissues over time.

To participate in this trial, women aged 65 to 74 may be eligible if they are premenopausal, peri-menopausal, or postmenopausal. For those specifically looking at the laser treatment effects, only postmenopausal women with genitourinary syndrome of menopause can join. Participants can expect to undergo imaging tests and possibly receive laser treatment while providing important information to help improve vaginal health care for women. Important exclusions include women with certain medical histories like pelvic radiation, those who are currently pregnant or breastfeeding, or those who have recently used hormone therapy.

Gender

FEMALE

Eligibility 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

About University Of California, Irvine

The University of California, Irvine (UCI) is a leading research institution renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a robust infrastructure for clinical research, UCI fosters interdisciplinary collaboration among its esteemed faculty and researchers, aiming to translate scientific discoveries into effective therapeutic solutions. The university prioritizes ethical standards and participant safety while addressing critical healthcare challenges across various fields, including cancer, neurology, and public health. UCI's dedication to excellence in research and education positions it as a pivotal contributor to the advancement of clinical science and patient care.

Locations

Irvine, California, United States

Costa Mesa, California, United States

Patients applied

0 patients applied

Trial Officials

Felicia Lane, MD

Principal Investigator

UC Irvine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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