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

NCT05443698 | Completed FDA Device

• 1 other identifier: 016
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fertility Risk

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• False Positives

  6 weeks

• Performance Task of Independent Readers

  6 weeks

• Box Opening

  6 weeks

• Patient Identifier

  6 weeks

• Probe Cover

  6 weeks

Study Arms (1)

Ultrasound Device

OTHER

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

Interventions

Transvaginal ultrasound DEVICE

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.

Ultrasound Device

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: Woman, as defined by sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Turtle Health, Inc.: lead

Study Sites (2)

Virtual Site

Boston, Massachusetts, 02110, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (3)

• Chung EH, Petishnok LC, Conyers JM, Schimer DA, Vitek WS, Harris AL, Brown MA, Jolin JA, Karmon A, Styer AK. Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment. Obstet Gynecol. 2022 Apr 1;139(4):561-570. doi: 10.1097/AOG.0000000000004698. Epub 2022 Mar 10.

  PMID: 35271530 BACKGROUND

• Birch Petersen K, Maltesen T, Forman JL, Sylvest R, Pinborg A, Larsen EC, Macklon KT, Nielsen HS, Hvidman HW, Nyboe Andersen A. The Fertility Assessment and Counseling Clinic - does the concept work? A prospective 2-year follow-up study of 519 women. Acta Obstet Gynecol Scand. 2017 Mar;96(3):313-325. doi: 10.1111/aogs.13081. Epub 2017 Feb 3.

  PMID: 27990627 BACKGROUND

• Farquhar C, Ekeroma A, Furness S, Arroll B. A systematic review of transvaginal ultrasonography, sonohysterography and hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal women. Acta Obstet Gynecol Scand. 2003 Jun;82(6):493-504. doi: 10.1034/j.1600-0412.2003.00191.x.

  PMID: 12780419 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Independent Readers reviewing Imaging Exams will be fully blinded to participant health history and exam setting.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, single arm clinical trial

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: July 25, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)