Women's HealthHATCHNCT05282524
Helping Adults Perform Transvaginal Exams Via Coaching at Home
A study testing Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) in people with Women's Health, run by Turtle Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HATCH (Helping Adults Perform Transvaginal Exams Via Coaching at Home) Study: Protocol for Training Ultrasound Technologists to Conduct At-home, Remote Transvaginal Ultrasounds
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
- Being tested
- Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 visit (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start23 Mar 2022
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282524
- Sponsor's protocol ID
- 011
- Acronym
- HATCH
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HATCH (Helping Adults Perform Transvaginal Exams Via Coaching at Home) Study: Protocol for Training Ultrasound Technologists to Conduct At-home, Remote Transvaginal Ultrasounds
- ClinicalTrials.gov ID
- NCT05282524
- Acronym / sponsor ID
- HATCH / 011
- Conditions
- Women's Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Turtle Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulated patient | Experimental | Device: Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)Women recruited from a general population subject to inclusion/exclusion criteria, who will participate at a minimum four times in the study |
| Naive patient | Experimental | Device: Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision)Women recruited from a general population subject to inclusion/exclusion criteria, who will participate only once in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Naive patient, Simulated patient |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound performed by a woman herself (with remote healthcare professional supervision) in people with Women's Health, run by Turtle Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video quality of remote self-performed ultrasound exam (time frame: 1 visit (up to 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.