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

Turtle Health, Inc.365 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

365

Conditions

Fertility Risk

Interventions

Transvaginal ultrasoundDEVICE

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.

Eligibility

Sex: FEMALEMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Virtual Site

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 weeks

Secondary Outcomes

False Positives

Rate of false positives of 'significant findings'

Time frame: 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.

Time frame: 6 weeks

Box Opening

Patient opens box at correct time (not early)

Time frame: 6 weeks

Patient Identifier

Correct patient is identified by tech and tests (not wrong patient)

Time frame: 6 weeks

Probe Cover

Patient correctly applies probe cover and uses it successfully during the scan

Time frame: 6 weeks

Correct Cavity

Data from ClinicalTrials.gov

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