NCT05443698

SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)

Sonograms Enable Looking Forward- Get Your iNformation 1 Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Turtle Health, Inc. · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This clinical trial will evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

Detailed description

Those images will be assessed for their image quality by qualified Independent Readers. The study is intended to assess the ability of at home imaging performed with the Turtle Health Ultrasound Scanner to reliably produce quality images as compared to objective performance criteria set by the American Institute of Ultrasound in Medicine (AIUM). The clinical investigation is intended to extend the findings of a published trial (SELF-HELP) to real-world performance. Each participant will have imaging performed at-home. The at-home imaging will be conducted using the Turtle Health Ultrasound Scanner, manipulated by the participant and guided in real time by a remote ultrasound technologist that has received special training with the device. Home imaging will follow the procedures included in planned device labeling. Imaging obtained will include, at minimum, each of the specific imaging views and components defined in the "American Institute of Ultrasound in Medicine (AIUM) Case Study Submission Requirements: Gynecologic Ultrasound". Imaging Scans will be assessed by at least two (2) independent readers who are physicians expert in the interpretation of transvaginal ultrasound gynecologic imaging studies. Images will have participant name redacted and each independent reader will be blinded to any participant information other than the images themselves. They will also be blinded to the assessments of the other readers. In-clinic Imaging Scans obtained from either or both of previous trials and in-clinic scans will be included in rating batches for calibration.

Conditions

• Fertility Risk

Interventions

Type	Name	Description
DEVICE	Transvaginal ultrasound	Adult women in the U.S. who are eligible for the ultrasound trial on the basis of the inclusion/exclusion criteria will complete an at home transvaginal ultrasound guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2022-07-05
• Last updated: 2023-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study