Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687189
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2020-12-04
Brief Title:
Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
Sponsor:
Turtle Health Inc
Organization:
Turtle Health Inc
Study Overview
Official Title:
SELF-HELP Validation Study Sonograms Enable Looking Forward - Home Examinations Led by Providers
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SELF-HELP
Brief 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None