Trials / Completed
CompletedNCT05282524
Helping Adults Perform Transvaginal Exams Via Coaching at Home
HATCH (Helping Adults Perform Transvaginal Exams Via Coaching at Home) Study: Protocol for Training Ultrasound Technologists to Conduct At-home, Remote Transvaginal Ultrasounds
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Turtle Health, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To train ultrasound technologists (equivalently called sonographers) in remote ultrasound guidance. To capture imaging of the gynecologic organs visible on home ultrasound and pertinent to clinical care, specifically the ovaries and uterus. To train the independent readers, both obstetricians \& gynecologists (OB/GYNs) and reproductive endocrinologists (REIs), who will evaluate home ultrasound images over time in subsequent clinical trials.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) | Imaging performed by woman on herself with remote healthcare professional (HCP) supervision. 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
- 2022-03-23
- Primary completion
- 2023-02-07
- Completion
- 2023-02-07
- First posted
- 2022-03-16
- Last updated
- 2023-03-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05282524. Inclusion in this directory is not an endorsement.