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To train ultrasound technologists (equivalently called sonographers) in remote ultrasound guidance.
To capture imaging of the gynecologic organs visible on home ultrasound and pertinent to clinical care, specifically the ovaries and uterus.
To train the independent readers, both obstetricians & gynecologists (OB/GYNs) and reproductive endocrinologists (REIs), who will evaluate home ultrasound images over time in subsequent clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulated patient | Experimental | Women recruited from a general population subject to inclusion/exclusion criteria, who will participate at a minimum four times in the study |
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| Naive patient | Experimental | Women recruited from a general population subject to inclusion/exclusion criteria, who will participate only once in the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) | Device | Imaging performed by woman on herself with remote healthcare professional (HCP) supervision. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Video quality of remote self-performed ultrasound exam | Determination of whether each organ view is 'diagnostic quality' or 'not diagnostic quality' based on American Institute of Ultrasound in Medicine (AIUM) criteria/guidelines | 1 visit (up to 1 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual metasite | Boston | Massachusetts | 02110 | United States |
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