Trials / Withdrawn
WithdrawnNCT05509322
Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial
Care Expansion Across Remote Environments - Substudy of the SELF-GYN [Sonograms Enable Looking Forward - Get Your iNformation] Extension - I Trial
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Turtle Health, Inc. · Industry
- Sex
- Female
- Age
- 25 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
This real-world, interventional sub-study will evaluate the impact of potential payer subsidies for Turtle Health at-home consults on subsequent interactions with the healthcare system within select sub-populations of interest.
Detailed description
The present study is a sub-study of the SELF-GYN1 study. The SELF-GYN1 study is a multicenter study designed to 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. In addition to the main questions of the SELF-GYN1 study, additional questions related to patient decision-making and pricing dynamics for patients who purchase patient's decisions to purchase a fertility consult alongside enrolling in the SELF-GYN1 trial, will be studied at Mayo Clinic, through providing subsidies for the purchasing of the fertility consult.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Subsidy for fertility consult | Some participants will receive a subsidy when they purchase the fertility consult. |
| OTHER | Invitation to purchase fertility consult | Some participants will receive an invitation from their health center to purchase an at-home fertility consult. |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2023-04-10
- Completion
- 2023-04-10
- First posted
- 2022-08-22
- Last updated
- 2023-04-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05509322. Inclusion in this directory is not an endorsement.