Skip to main content
OpenTrials
Completed

NCT Number: NCT05282524

Helping Adults Perform Transvaginal Exams Via Coaching at Home

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virtual metasite

Boston, Massachusetts, 02110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Video quality of remote self-performed ultrasound exam

    Time frame: 1 visit (up to 1 hour)

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

Sponsors and collaborators

Lead sponsor

Turtle Health, Inc.

Industry

Registry information

Official study title

HATCH (Helping Adults Perform Transvaginal Exams Via Coaching at Home) Study: Protocol for Training Ultrasound Technologists to Conduct At-home, Remote Transvaginal Ultrasounds

Acronym: HATCH

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.