SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial) (NCT05443698) | Clinical Trial Compass
CompletedNot Applicable
SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)
United States365 participantsStarted 2022-07-25
Plain-language summary
This clinical trial will evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.
Who can participate
Age range
22 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman, as defined by sex at birth
* Age 22 years or older at the time of eligibility screening
* Premenopausal
* BMI \< 40 kg/m2
* Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report
* English-speaking and able to follow verbal instructions of the remote ultrasound technologist as determined by the ability to complete the consent process unassisted
* Ability to manipulate a 1 lb. weight by hand
* Residence in state where a PI holds a valid license to practice medicine
* Ability to receive signature delivery of the investigational ultrasound device
* Ability to return the investigational ultrasound device by specified instructions
Exclusion Criteria:
* Pregnant or may be pregnant
* Has recently given birth, and has had fewer than 3 postpartum menstrual cycles
* Has 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
* Has changed birth control within the current menstrual cycle (one 'washout' cycle is required)
* Turtle Health employees
* Has known cancer of a pelvic organ, not currently in remission
* Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who chang…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.