Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers

Conditions
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Fertility Risk

Intervention / Treatment
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* Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with a known history of submucosal fibroids<br> | Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)<br>* Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.<br>|
| Experimental: Women recruited from a general population subject to I/E criteria<br> | Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)<br>* Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically comparable video quality of supervised 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. | Day 1 (self-performed scan) | 
| Clinically comparable video quality of 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. | Day 2 (HCP-performed scan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans | Evaluated by survey post ultrasound administration. Calculated as a standard NPS: 9/10 scores = 1; 7/8 scores = 0; 0-6 scores = -1, missing = 0. | Day 1 (self-performed scan) and Day 2 (HCP-performed scan) | 
| Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans | Difference between antral follicle count (AFC) identified in both ovaries among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other) | 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 | Difference between accurate identification of submucosal fibroids among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other) | 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 | Difference between false positive rate among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other). An all-cause false positive will be defined as a subject where pathology requiring in-person follow-up is identified on the supervised self-performed exam, but not substantiated by identification by the HCP-administered exam. | Day 1 (self-performed scan) and Day 2 (HCP-performed scan) |