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Study objective embedded into future study
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To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with a known history of submucosal fibroids (that have not been surgically removed) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) | Device | 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 |
|---|---|---|
| Sensitivity of the at-home ultrasound for submucosal fibroids | Qualified independent raters will be asked if they see a submucosal fibroid on the uterine videos. Answer options are: Yes, definitely; Almost certain; Possibly; Unlikely; No; N/A. In order to consider a fibroid present, either (1) two raters must answer "Almost certain" to having seen a submucosal fibroid or (2) one must answer "Yes definitely" to having seen a submucosal fibroid | Up to 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtual metasite | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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