Trials / Withdrawn
WithdrawnNCT05004870
Home Examinations Researching and Understanding Submucosal Evaluations
Home Examinations Researching and Understanding Submucosal Evaluations: Prospective, Virtual Study to Demonstrate Sensitivity of Submucosal Fibroids on At-home Ultrasound (Follow up to SELF-HELP Study)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Turtle Health, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) | 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
- 2021-12-16
- Primary completion
- 2021-12-17
- Completion
- 2021-12-17
- First posted
- 2021-08-13
- Last updated
- 2022-04-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05004870. Inclusion in this directory is not an endorsement.