Helping Adults Perform Transvaginal Exams Via Coaching at Home

NCT05282524 | Completed FDA Device

• 1 other identifier: 011
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Video quality of remote self-performed ultrasound exam

  Determination of whether each organ view is 'diagnostic quality' or 'not diagnostic quality' based on American Institute of Ultrasound in Medicine (AIUM) criteria/guidelines

  1 visit (up to 1 hour)

Study Arms (2)

Simulated patient

EXPERIMENTAL

Women recruited from a general population subject to inclusion/exclusion criteria, who will participate at a minimum four times in the study

Device: Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)

Naive patient

EXPERIMENTAL

Women recruited from a general population subject to inclusion/exclusion criteria, who will participate only once in the study

Device: Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)

Interventions

Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) DEVICE

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.

Naive patient; Simulated patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 and over who have not gone through menopause (defined as no menstruation for at least 12 months, not explained by other causes)
• Women with body mass index (BMI) up to 40
• Women who speak English, assessed through screening questions
• Women with at least a high school degree or equivalent (e.g., General Educational Development (GED) or similar)
• Women located in Massachusetts
• Women who are able to safely receive delivery of the ultrasound scanner
• Women between cycle days 3 and 10 at the time of testing as a mitigation against potential inadvertent early fetal exposure; or intrauterine device (IUD) users who do not have a menses
• Women who have all three primary gynecological organs: left ovary, right ovary, and uterus

You may not qualify if:

• Women with BMI over 40
• Women who do not speak English natively or fluently
• Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
• Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
• Women who are currently pregnant or may be pregnant
• Women who have had a hysterectomy or oophorectomy
• Women who have changed birth control within the current menstrual cycle. (One 'washout' cycle is required)
• Women with cancer of any pelvic organ
• Women who are not able to schedule an exam while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made may be excluded.
• Women with disabilities are excluded only if their disability precludes their ability to manipulate an ultrasound and follow technologist instructions

Sponsors & Collaborators

• Turtle Health, Inc.: lead

Study Sites (1)

Virtual metasite

Boston, Massachusetts, 02110, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: March 23, 2022
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)