SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)

Sonograms Enable Looking Forward- Get Your iNformation 1 Trial

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.

Those images will be assessed for their image quality by qualified Independent Readers. The study is intended to assess the ability of at home imaging performed with the Turtle Health Ultrasound Scanner to reliably produce quality images as compared to objective performance criteria set by the American Institute of Ultrasound in Medicine (AIUM).

The clinical investigation is intended to extend the findings of a published trial (SELF-HELP) to real-world performance.

Each participant will have imaging performed at-home. The at-home imaging will be conducted using the Turtle Health Ultrasound Scanner, manipulated by the participant and guided in real time by a remote ultrasound technologist that has received special training with the device. Home imaging will follow the procedures included in planned device labeling. Imaging obtained will include, at minimum, each of the specific imaging views and components defined in the "American Institute of Ultrasound in Medicine (AIUM) Case Study Submission Requirements: Gynecologic Ultrasound".

Imaging Scans will be assessed by at least two (2) independent readers who are physicians expert in the interpretation of transvaginal ultrasound gynecologic imaging studies. Images will have participant name redacted and each independent reader will be blinded to any participant information other than the images themselves. They will also be blinded to the assessments of the other readers. In-clinic Imaging Scans obtained from either or both of previous trials and in-clinic scans will be included in rating batches for calibration.

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 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
• Previous hysterectomy or oophorectomy
• Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus
• Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial)