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Helping Adults Perform Transvaginal Exams Via Coaching at Home

NCT05282524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-03-06

No results posted yet for this study

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

  • Women's Health

Interventions

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.

Sponsors & Collaborators

  • Turtle Health, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2023-02-07
Completion
2023-02-07
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 NCT05282524 on ClinicalTrials.gov