CompletedNot Applicable

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

United States56 participantsStarted 2021-02-27

Plain-language summary

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.

Who can participate

Age range18 Years – 38 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinically comparable video quality of supervised self-performed scan

Timeframe: Day 1 (self-performed scan)

Clinically comparable video quality of HCP-performed scan

Timeframe: Day 2 (HCP-performed scan)

Trial details

NCT IDNCT04687189

SponsorTurtle Health, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-30