Clinical trial NCT05443698: SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)
Official title: Sonograms Enable Looking Forward- Get Your iNformation 1 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Risk
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 365
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional, single arm clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Image Quality
timeFrame: 6 weeks
measure: Net Promoter Score (NPS)
timeFrame: 6 weeks
Secondary outcomes:
measure: False Positives
timeFrame: 6 weeks
measure: Performance Task of Independent Readers
timeFrame: 6 weeks
measure: Box Opening
timeFrame: 6 weeks
measure: Patient Identifier
timeFrame: 6 weeks
measure: Probe Cover
timeFrame: 6 weeks
measure: Correct Cavity
timeFrame: 6 weeks
measure: Timely Return
timeFrame: 6 weeks
measure: Shipping Damage
timeFrame: 6 weeks
measure: Successful Return
timeFrame: 6 weeks
measure: Minor Pain or Discomfort
timeFrame: 6 weeks
measure: All Other Adverse Events
timeFrame: 6 weeks
measure: Successful Reprocessing
timeFrame: 6 weeks
measure: Ultrasound technologist satisfaction
timeFrame: 6 months
measure: Ultrasound technologist availability
timeFrame: 6 months
measure: Ultrasound technologist safety
timeFrame: 6 months
measure: Correct setting of care guess rate
timeFrame: 6 months
measure: Sub-group exploratory endpoints: Endpoint 1
timeFrame: 1 year
measure: Sub-group exploratory endpoints: Endpoint 2
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Virtual Site
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.