SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinically comparable video quality of supervised self-performed scan
研究概览
简要总结
To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.
详细描述
Today, pro-fertility information is generally unavailable to healthy women; clinically meaningful in-clinic testing is limited by physician availability and patient willingness to undergo testing in-clinic, while home testing is limited to hormonal bloodwork which is insufficient on its own and has high false positives. Sponsor is developing home telemedicine transvaginal ultrasound as part of a home fertility assessment. Sponsor wishes to demonstrate the ability to obtain interpretable images, in women of varying body habitus, reproductive age, and reproductive status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 and 38 inclusive
- •Women with BMI up to 40
- •Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent
- •N = 30 will be recruited from the general population, e.g., no known previous issues
- •N = 15 will be positive controls with submucosal fibroids
- •Women who are in driving distance from Boston (including Vermont and Connecticut); these states are covered by the PI's medical license during the COVID emergency
- •Women between cycle days 3 and 10 at the time of testing; or IUD users who do not have a menses
排除标准
- •Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
- •Women with BMI over 40
- •Women who do not speak English natively or fluently
- •Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
- •Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
- •Women who are currently pregnant or may be pregnant
- •Any woman the PI believes is not capable of giving independent, informed consent
- •Turtle Health employees
研究组 & 干预措施
Women with a known history of submucosal fibroids
干预措施: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) (Device)
Women recruited from a general population subject to I/E criteria
干预措施: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) (Device)
结局指标
主要结局
Clinically comparable video quality of supervised self-performed scan
时间窗: Day 1 (self-performed scan)
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
Clinically comparable video quality of HCP-performed scan
时间窗: Day 2 (HCP-performed scan)
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
次要结局
- Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans(Day 1 (self-performed scan) and Day 2 (HCP-performed scan))
- Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans(Day 1 (self-performed scan) and Day 2 (HCP-performed scan))
- Change in detection accuracy for major submucosal fibroids between supervised self-performed and HCP-performed scans in the known history of submucosal fibroids arm(Day 1 (self-performed scan) and Day 2 (HCP-performed scan))
- Change in all-cause false positive rate between supervised self-performed and HCP-performed scans in the general population arm(Day 1 (self-performed scan) and Day 2 (HCP-performed scan))