SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)
NCT05443698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365
Last updated 2023-07-17
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.
Conditions
- Fertility Risk
Interventions
- 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.
Sponsors & Collaborators
-
Turtle Health, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2023-07-14
- Completion
- 2023-07-14
- FDA Device
- Yes
Countries
- United States
Study Locations
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