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The SELF-GYN1 trial was a prospective, interventional, nonrandomized clinical trial.
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The SELF-GYN1 trial took place from July 2022 to July 2023.
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Participants were recruited online and through physician referrals in 10 states and Washington D.C.
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Recruitment occurred in Florida, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, Texas, Utah, Virginia, Vermont, and Washington D.C.
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Eligible participants were premenopausal women ages 22 to 50 who spoke English, had a body mass index less than 40, and were able to manipulate a 1-pound weight by hand.
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Pregnant, potentially pregnant, and newly postpartum women were excluded from the study.
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Individuals with a history of gynecologic malignant neoplasm, hysterectomy, or oophorectomy were excluded from the study.
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The study included 265 patients.
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263 participants completed their at-home pelvic ultrasonography with verbal guidance from a trained remote sonographer with real-time access to the images.
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The mean participant age was 32.4 years.
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The mean participant body mass index was 27.
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84.2% of the sample was white.
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91.3% of the sample was non-Hispanic or Latino.
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Two participants were removed from the analysis because their sonographer provided inferior guidance.
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96.2% of at-home ultrasound scans taken by patients with verbal assistance from a trained remote sonographer met diagnostic quality.
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Net promoter scores were 59.1 for at-home ultrasonography compared to 25.4 for in-clinic scans.
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The adjusted difference in net promoter scores was 33.7 (95% CI 23.3-44.0, z=6.35, P<0.001).
Alessandra Ainsworth, MD, Mayo Clinic
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"Not only was this technology feasible and safe, but it was also preferred by participants."
Alessandra Ainsworth, MD, Mayo Clinic
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"Image quality in this study relied heavily, if not exclusively, on sonographer coaching."
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The ultrasound scanners were provided by Turtle Health.
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Turtle Health funded the study.
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The Turtle Health product used in the study is FDA cleared for use by healthcare professionals in healthcare settings.
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Trained physicians reviewed images taken at-home during this study or in-clinic during the SELF-HELP study in a blinded assessment.
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Physicians guessed the correct setting 56% of the time.
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Only 11% of the images reviewed were collected in-clinic.
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Gynecologic pathology was identified in 26.2% of patients.
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Identified pathologies included uterine fibroids (50.7%), complex cysts (34.8%), and other findings such as endometrial polyps or malpositioned intrauterine devices (14.5%).
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Elevated BMI was the most common variable linked with nondiagnostic images.
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Women shorter than 4'6" had difficulty manipulating the probe.
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Two-thirds of patients completed post-exam questionnaires 3 days after the procedure.
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62% of patients completed post-exam questionnaires 3 weeks after the procedure.
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Among respondents to the first survey, 11% reported minor pain or discomfort.
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Reported concerns included thick vaginal discharge, stained underwear from ultrasonography gel, shoulder pain from reaching different positions, and mild vaginal burning.
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At the 3-week survey, 1.8% of respondents reported minor pain or discomfort.
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Patients reported pain from pressure to image the left ovary and the development of a cyst deemed not due to the ultrasonography.
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None of the reported instances of pain or discomfort were classified as adverse events.
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Sonographers reported high satisfaction with both at-home and in-clinic work.
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Sonographers preferred remote guiding and reported lower pain doing so.
Nikki Zite, MD, MPH, University of Tennessee Medical Center
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"While they did show it was possible to obtain usable images, the training required for their technicians along with the complexity and risk of mailing these expensive devices would limit utilization to very specific patient populations, most likely those undergoing assisted reproductive techniques."
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Alessandra Ainsworth is affiliated with the Mayo Clinic in Rochester, Minnesota.
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Nikki Zite was not involved in the SELF-GYN1 study.
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