NCT04687189

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Turtle Health, Inc. · Industry
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Fertility Risk

Interventions

Type	Name	Description
DEVICE	Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)	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.

Timeline

• Start date: 2021-02-27
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-12-29
• Last updated: 2021-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study