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Home Examinations Researching and Understanding Submucosal Evaluations

NCT05004870 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-29

No results posted yet for this study

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

  • Fertility Issues

Interventions

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.

Sponsors & Collaborators

  • Turtle Health, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05004870 on ClinicalTrials.gov