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 range22 Years
SexFEMALE
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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…