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

通过多功能 OCT/OCTA 内窥镜持续监测和管理阴道健康

• 批准号: 10297772
• 负责人: ZHONGPING CHEN
• 金额: $ 194.69万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10297772
• 关键词: Ablation; Adverse effects; Affect; Aftercare; Alternative Therapies; Angiography; Area; Atrophic; Beds; Benign; Biochemistry; Biomechanics; Biopsy; Blood Vessels; Blood coagulation; Burn injury; California; Carbon Dioxide; Caring; Cicatrix; Clinic; Clinical; Communities; Dermatology; Devices; Disease; Dose; Effectiveness; Endometrial Carcinoma; Endoscopes; Endoscopy; Epithelial; Estrogens; Evaluation; Female; Functional disorder; Future; Genitourinary system; Goals; Health; Image; Imaging Device; Imaging technology; Injury; Institutes; Lasers; Lead; Leadership; Life; Low-Level Laser Therapy; Medical; Medical center; Medicine; Menopausal Symptom; Menopausal Syndrome; Menopause; Molecular Biology; Monitor; Nail plate; Optical Coherence Tomography; Patient Monitoring; Patients; Pelvis; Physicians; Physiological; Procedures; Psoriasis; Quality of life; Reconstructive Surgical Procedures; Refractory; Reproducibility; Research; Risk; Safety; Scientist; Sex Functioning; Source; Structure; Supervision; Symptoms; System; Technology; Thick; Time; Tissues; Treatment Protocols; Universities; Vagina; Validation; Woman; alternative treatment; base; clinical translation; density; design; female reproductive system; follow-up; hormone therapy; human subject; image guided; imaging probe; imaging system; individualized medicine; ineffective therapies; insight; malignant breast neoplasm; microbiome; microbiome research; minimally invasive; negative affect; non-invasive imaging; novel therapeutics; patient screening; personalized management; point of care; prototype; reproductive organ; research study; response; screening; side effect; technology development; tool; treatment effect; treatment optimization; treatment strategy; wound healing

PROJECT SUMMARY Genitourinary Syndrome of Menopause (GSM) affects up to 50% of women and negatively affects their quality of life with regard to general health and sexual function. Hormone therapy is the most commonly performed procedure to supplement the natural estrogen, but health risk associated with long-term therapy exists. Recently, an alternative therapy has been proposed using fractional CO2 micro- ablation that may benefit patients that cannot receive hormone therapies. Although laser micro- ablation showed a clear benefit in dermatology, it remains controversial in female pelvic medicine. The main problem is that, without a clear indication to routinely perform an invasive biopsy for benign genitourinary changes, the pathophysiology of tissue response and factors leading to refractory symptoms remain poorly understood. Thus, this is an area of research that would greatly benefit from non-invasive imaging technologies such as Optical Coherence Tomography (OCT). Our long-term goal is to provide individualized patient management by screening patients who will benefit the most from laser therapy, optimize the laser duration and dose, and assess the need for follow-up care. To achieve this goal, we will develop a point-of-care endoscopic imaging system that combines OCT and OCT angiogram (OCTA) to obtain simultaneous information on structural and functional changes during the vaginal laser treatment. We further proposed to use 1.7 μm center wavelength swept-source laser to image 500 μm deeper than the traditional 1.3 μm laser. We will achieve our objectives by pursuing the following specific aims. Aim 1: Design and develop a 1.7 μm OCT/OCTA system and a multifunctional endoscope imaging probe. Aim 2: Establish the reproducibility of the integrated endoscope in human subjects by assessing vaginal tissue integrity in different demographic groups. Aim 3: Investigate the effects of laser ablation over a time course of several laser therapies and understand the tissue response. The endoscopic OCT/OCTA system will serve as a noninvasive biopsy tool in the gynecological practice and it can, non- invasively, provides structural and functional information about the tissue. This will provide clinicians and scientists with an important tool to screening the patients that will benefit from the laser, monitor the progression of laser therapy, and evaluate the tissue response from the laser treatment and further individualize treatment strategies. The proposed research is expected to have a significant impact on image-guided laser therapy and the management of GSM.

项目摘要 绝经期泌尿生殖系统综合征（GSM）影响高达50%的妇女，并对妇女的健康产生负面影响。 他们在一般健康和性功能方面的生活质量。激素疗法是最 通常进行的程序，以补充天然雌激素，但健康风险与 存在长期治疗。最近，已经提出了一种替代疗法，使用分数CO2微- 消融术可能使无法接受激素治疗的患者受益。虽然激光微- 消融术在皮肤病学中显示出明显的益处，但在女性盆腔医学中仍存在争议。 主要的问题是，没有明确的指征，常规进行侵入性活检的良性 泌尿生殖系统变化、组织反应的病理生理学和导致难治性症状的因素 人们对它了解仍然很少。因此，这是一个研究领域，将大大受益于非侵入性 成像技术，如光学相干断层扫描（OCT）。我们的长期目标是提供 通过筛选从激光治疗中获益最多的患者进行个性化患者管理， 优化激光持续时间和剂量，并评估后续护理的需求。为了实现这一目标，我们 将开发结合OCT和OCT血管造影的即时内窥镜成像系统 （OCTA）以获得阴道激光期间结构和功能变化的同时信息 治疗进一步提出了用1.7 μm中心波长扫频光源成像500 μm的方案 比传统的1.3 μm激光器更深。我们会致力达致以下目标： 目标。目的1：设计并研制1.7 μ mOCT/OCTA系统和多功能内窥镜成像系统 探针目的2：通过评估，确定集成内窥镜在人类受试者中的再现性 阴道组织的完整性。目的3：研究激光消融的效果 在几种激光治疗的时间过程中，并了解组织反应。内窥镜 OCT/OCTA系统将在妇科实践中作为一种无创活检工具， 侵入性地提供关于组织的结构和功能信息。这将为临床医生提供 科学家们有一个重要的工具来筛选将从激光中受益的病人，监测 激光治疗的进展，并评估激光治疗的组织反应， 个性化治疗策略。预计这项研究将对以下方面产生重大影响 图像引导激光治疗和GSM的管理。