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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sonograms Enable Looking Forward- Get Your iNformation 1 Trial

Conditions
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Fertility Risk

Intervention / Treatment
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* Device: Transvaginal ultrasound


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, interventional, single arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound Device<br>All women who choose to enroll in the trial will undergo an at home transvaginal ultrasound guided by real-time remote supervision from a qualified and specially trained ultrasound technologist. | Device: Transvaginal ultrasound<br>* Adult women in the U.S. who are eligible for the ultrasound trial on the basis of the inclusion/exclusion criteria will complete an at home transvaginal ultrasound guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality | Each Independent Reader will make a determination of whether each Imaging Scan is of 'diagnostic quality' or 'not diagnostic quality', in its totality, for the purpose of a diagnostic gynecological ultrasound examination. | 6 weeks | 
| Net Promoter Score (NPS) | All subjects will be asked to complete the question 'How likely are you to recommend the experience to a friend or colleague?.' It is expected that a high share of patients will report a positive NPS. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False Positives | Rate of false positives of 'significant findings' | 6 weeks | 
| Performance Task of Independent Readers | Each Independent Reader will assess the suitability of the Imaging Study for use on each of ten specific imaging tasks defined by the AIUM practice parameters as required for a high quality two-dimensional gynecological ultrasound imaging study. | 6 weeks | 
| Box Opening | Patient opens box at correct time (not early) | 6 weeks | 
| Patient Identifier | Correct patient is identified by tech and tests (not wrong patient) | 6 weeks | 
| Probe Cover | Patient correctly applies probe cover and uses it successfully during the scan | 6 weeks | 
| Correct Cavity | Patient places probe in correct cavity (vaginal vs. anal) | 6 weeks | 
| Timely Return | Patient ships product back in a timely fashion | 6 weeks | 
| Shipping Damage | Rate at which probe is damaged in transit | 6 weeks | 
| Successful Return | Rate at which probe remains in working condition and able to be reprocessed | 6 weeks | 
| Minor Pain or Discomfort | Rate at which subjects report minor pain, discomfort, or similarly mild symptoms lasting under 24 hours | 6 weeks | 
| All Other Adverse Events | Rate at which subjects report adverse events, side effects, or other sequelae other than minor pain, discomfort, or similarly mild symptoms lasting under 24 hours | 6 weeks | 
| Successful Reprocessing | Number of probes undergoing reprocessing that are reprocessed properly per internal standard operating procedures | 6 weeks | 
| Ultrasound technologist satisfaction | Difference in average weekly satisfaction between in-person and virtual settings based on survey responses | 6 months | 
| Ultrasound technologist availability | Estimation of weekly increase in personnel capacity enabled by device based on number of ultrasound technologists available. | 6 months | 
| Ultrasound technologist safety | Implied/potential estimation of injury reduction based on survey results | 6 months | 
| Correct setting of care guess rate | Including in-clinic 'control' data from previous study or from in-clinic scans with same device | 6 months | 
| Sub-group exploratory endpoints: Endpoint 1 | Results from the primary end point Image Quality will also be reported by sub-populations of interest. The sub-populations are: Class I obese patients (BMI between 30 and 35, inclusive) Class II+ obese patients (BMI greater than 35) Aged 40 or older Residing in 'completely rural' or 'mostly rural' counties Symptoms indicating possible pathology (where available) No record of visiting a doctor in the 24 months prior to enrollment (where available) Educational attainment less than some college Identifying as Hispanic or Latino Identifying as American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White Multiple identities selected | 1 year | 
| Sub-group exploratory endpoints: Endpoint 2 | Results from the primary end point Net Promoter Score (NPS) will also be reported by sub-populations of interest. There sub-populations are: Class I obese patients (BMI between 30 and 35, inclusive) Class II+ obese patients (BMI greater than 35) Aged 40 or older Residing in 'completely rural' or 'mostly rural' counties Symptoms indicating possible pathology (where available) No record of visiting a doctor in the 24 months prior to enrollment (where available) Educational attainment less than some college Identifying as Hispanic or Latino Identifying as American Indian or Alaska Native Asian Black or African American Native Hawaiian or Other Pacific Islander White Multiple identities selected | 1 year |