Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study

NCT04687189 | Completed FDA Device

• 1 other identifier: 008
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.

Conditions

Fertility Risk

Outcome Measures

Primary Outcomes (2)

• Clinically comparable video quality of supervised self-performed scan

  As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.

  Day 1 (self-performed scan)

• Clinically comparable video quality of HCP-performed scan

  As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.

  Day 2 (HCP-performed scan)

Secondary Outcomes (4)

• Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans

  Day 1 (self-performed scan) and Day 2 (HCP-performed scan)

• Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans

  Day 1 (self-performed scan) and Day 2 (HCP-performed scan)

• Change in detection accuracy for major submucosal fibroids between supervised self-performed and HCP-performed scans in the known history of submucosal fibroids arm

  Day 1 (self-performed scan) and Day 2 (HCP-performed scan)

• Change in all-cause false positive rate between supervised self-performed and HCP-performed scans in the general population arm

  Day 1 (self-performed scan) and Day 2 (HCP-performed scan)

Study Arms (2)

Women with a known history of submucosal fibroids

EXPERIMENTAL

Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Women recruited from a general population subject to I/E criteria

EXPERIMENTAL

Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Interventions

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) DEVICE

Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Women recruited from a general population subject to I/E criteria; Women with a known history of submucosal fibroids

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18 and 38 inclusive
• Women with BMI up to 40
• Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent
• N = 30 will be recruited from the general population, e.g., no known previous issues
• N = 15 will be positive controls with submucosal fibroids
• Women who are in driving distance from Boston (including Vermont and Connecticut); these states are covered by the PI's medical license during the COVID emergency
• Women between cycle days 3 and 10 at the time of testing; or IUD users who do not have a menses

You may not qualify if:

• Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
• Women with BMI over 40
• Women who do not speak English natively or fluently
• Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
• Women who have 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
• Women who are currently pregnant or may be pregnant
• Any woman the PI believes is not capable of giving independent, informed consent
• Turtle Health employees

Sponsors & Collaborators

• Turtle Health, Inc.: lead

Study Sites (1)

Virtual metasite

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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 DERIVED

Study Officials

• Aaron Styer

  Harvard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 29, 2020
• Study Start: February 27, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

US (1)