Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/Angiography Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vaginal epithelial thickness (VET)
研究概览
简要总结
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:
- 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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •. Women who are premenopausal, peri-menopausal and postmenopausal
- •. Postmenopausal women with genitourinary syndrome of menopause
排除标准
- •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
研究组 & 干预措施
CO2 Laser +OCT
Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment
干预措施: CO2 laser (Device)
OCT only
Premenopausal, peri-menopausal and postmenopausal women who will only get one time OCT scan
干预措施: OCT (Device)
CO2 Laser +OCT
Postmenopausal women with genitourinary syndrome of menopause who will receive CO2 vaginal laser treatment
干预措施: OCT (Device)
结局指标
主要结局
Vaginal epithelial thickness (VET)
时间窗: 2 years
Vaginal epithelium thickness measured with the OCT.
次要结局
- blood vessel density(2 years)
- Lactobacillus abundance(2 years)
- Vaginal Health Index (VHI)(2 years)
研究者
Felicia Lane
Chair, Division of FPMRS
University of California, Irvine