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Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study

NCT04687189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-05-18

No results posted yet for this study

Summary

To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.

Conditions

  • Fertility Risk

Interventions

DEVICE

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. 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

Principal Investigators

  • Aaron Styer · Harvard University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-27
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04687189 on ClinicalTrials.gov